Science-Based Solutions f or Food Saf ety and Quality Prof essionals Worldwide

OCTOBER/NOVEMBER 2022

Supply Chain A Year in Review

Dairy HACCP Pre-Harvest Controls Ongoing

Through the Years for Reducing Improvements
Salmonella in Poultry to Meat Safety
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CA's Leafy Greens under Scrutiny; More Root-

Cause Analysis Needed?
With the U.S. Food and Drug Administration's (FDA's) summer announcement that it will again conduct targeted
sampling of leafy greens as part of its Leafy Greens STEC Action Plan (LGAP),1 what does that mean for leafy
greens growers? Farms and ranches located in the Salinas Valley may already have FDA officials on their land
taking product samples—if the farms were identified through traceback investigations as being potentially
associated with a foodborne illness outbreak.

In an effort to avoid the risk of Shiga toxin-producing Escherichia coli (STEC) contamination of leafy greens, FDA
is concentrating its sampling efforts2 on the California growing region, as it has been the source of several
foodborne illness outbreaks across North America in recent years. Sampling began in mid-September 2022 and
will run through October 2022, and all samples will be tested for several species of Salmonella and STEC. In
addition to taking around 240 product samples, FDA may collect environmental samples such as water, soil, and
animal waste, as appropriate, based on observations made at the time of sampling and a farm or ranch's past
inspection history.

FDA's summary report3 for its 2021 Salinas Valley sampling, conducted from May through November of last year,
resulted in three positive findings out of the 498 samples tested. FDA detected STEC in one red leaf sample and
one iceberg sample, as well as Salmonella enterica subspecies diarizone (which is rarely associated with clinical
illness) in one green leaf sample. In their 2022 meetings with leafy greens producers in California, FDA food
safety experts will also explore concerns about the sanitary design of harvest equipment and how field production
and processing practices may be contributing to contamination events—two complex areas that are worthy of
closer examination through root-cause analysis.

Sampling helps identify if a problem exists. Root-cause analysis helps identify the changes that need to be made to
prevent a problem from recurring. In the produce sector, root-cause analysis is more complex than for other food
types due to the variable nature of environmental conditions and inputs in growing areas, as well as the ability of
produce crops to be impacted by surrounding activities. Produce root-cause analysis is also made more complex by
the highly perishable nature and variable characteristics of the products, the seasonally inconsistent nature of
risks, the unique setup of each growing operation, the variability of monitoring equipment and record-keeping, as
well as the difficulty of replicating preharvest conditions for performing the analysis.4 

Amid these complexities, methods are available for systematic root-cause assessment and analysis that help
identify the prevalence or proximity to hazards; the concentration of those hazards and probability of exposure to
them; the outcome and severity of risk of exposure to the hazards; and the probability of contamination,
recurrence, and spread. In produce, hazards identification does not always mean pinpointing one clear, singular
factor as the cause of contamination. Many factors may work in concert to cause an issue. A number of complex
and complicated interactions occur in a growing environment on a daily basis, and predicating factors may
disappear over time, making it difficult to diagnose the original source of contamination.4

Root-cause analysis requires experience, critical reasoning, and an appropriate level of skepticism. While produce
root-cause analysis is often not definitive, it is still an important tool to help mitigate the risk of contamination in
leafy greens and the foodborne illness outbreaks associated with this food type.

Regards,

Adrienne Blume,
Editorial Director

References

1. FDA. "Leafy Greens STEC Action Plan." September 8, 2022. https://www.fda.gov/food/foodborne-pathogens/leafy-greens-stec-action-plan.

2. "FDA's Leafy Greens Action Plan: FY2021 Sampling Results, Future Targeted Sampling." Food Safety Magazine. September 8, 2022.
https://www.food-safety.com/articles/7993-fdas-leafy-greens-action-plan-fy2021-sampling-results-future-targeted-sampling.

3. FDA. "Microbiological Surveillance Sampling: FY21 Sample Collection and Analysis of Lettuce Grown in Salinas Valley, CA." September 8, 2022.
https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling-fy21-sample-collection-and-analysis-lettuce-
grown-salinas.

4. Eurofins US Food Group. "Produce Industry Root Cause Investigation Webinar." Trevor Suslow, Ph.D., Extension Research Specialist,
Department of Plant Sciences, University of California–Davis. YouTube. August 5, 2021. https://youtu.be/AhnSrX2j-KM.

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

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USDA FSIS Declares

Salmonella an
Adulterant in Breaded,
Stuffed Raw Chicken
Products
The U.S. Department of Agriculture's Food Safety and Inspection Service (USDA's FSIS) has announced that it will
declare Salmonella to be an adulterant in breaded and stuffed raw chicken products. By declaring Salmonella to be
an adulterant, FSIS will have the authority to ensure that contaminated products do not enter the market. The
action is part of FSIS' broader efforts to reduce Salmonella illnesses associated with poultry.

Breaded and stuffed raw chicken products are of particular concern because they have been linked to 14 foodborne
illness outbreaks and 200 illnesses since 1998. Breaded and stuffed raw chicken products are typically found in the
freezer section at grocery stores, and may cause confusion as they can appear cooked; FSIS states that efforts to
improve labeling for the products has not been effective at reducing consumer illnesses.

FSIS will propose to set the Salmonella limit of breaded and stuffed raw chicken products at 1 CFU/g. If the
products exceed the limit, then they will be considered adulterated and be subject to regulatory action. FSIS will
also consider public opinion on whether a different standard for adulteration, such as "zero tolerance" or
standards based on specific serotypes, would be more appropriate. The notice is expected to publish in the Federal
Register in autumn. After the proposal is finalized, FSIS will announce its final implementation plans and the date
on which it will begin routine testing for Salmonella in the specified products.

Total Diet Study for 2018–

2020 Reveals That No Foods
Exceed FDA Action Levels

The U.S. Food and Drug Administration (FDA) recently released its Total Diet Study (TDS) Report for Fiscal Years
(FY) 2018–2020. The report summarizes the analytical results of continuous testing done by FDA on food that is
collected from retail outlets. In FY 2018, FDA implemented a modernized TDS research design that included
streamlined analytical methods, a population-based sampling plan, and an updated food list. The modernized
approach increased surveillance of the U.S. food supply, with 87 food collections conducted in FY 2018–2020 that
resulted in the sampling of 3,276 food, beverage, and water products. Specifically, the TDS report provides the
analytical results for 3,241 samples of 305 foods and beverages analyzed for 21 element analytes, as well as 35
samples of bottled water analyzed for 22 element analytes. A subset of 54 samples including rice-containing
foods, juices, and wine were further analyzed for three arsenic species.

Toxic Elements Overview

The report states that key toxic elements of concern—lead, arsenic, cadmium, and mercury—were not detected in
the majority (68 percent) of analytical results. Highlighted findings include:

Lead was detected in 15 percent of samples, with the highest level detected reaching 63 parts per billion (ppb)

Arsenic was detected in 43 percent of samples, with the highest level detected reaching 10,900 ppb

Of the subset of 54 samples that were further tested for arsenic, the detected levels of inorganic arsenic
ranged from 6.1–103 ppb

Cadmium was detected in 61 percent of samples, with the highest level detected reaching 400 ppb

Mercury was detected in 8 percent of samples, with the highest level detected reaching 250 ppb.

Foods with FDA Action Levels Overview

The TDS report also underlines the fact that, for the TDS foods that are subject to FDA action levels or standards,
all results fell below FDA established levels. This includes apple juice, for which FDA set an action level of 10
ppb earlier in 2022. Apple juice also has an action level of 10 ppb for inorganic arsenic. Additional TDS foods with
FDA action levels include chocolate and hard candy with an action level of 100 ppb for lead, and infant rice cereal
with an action level of 100 ppb for inorganic arsenic. FDA standards for bottled water are 5 ppb for lead, 10 ppb
for arsenic, 5 ppb for cadmium, and 2 ppb for mercury.

The TDS report also states that, in FY 2019, FDA conducted additional sampling of baby foods. Types of baby
foods that were tested for TDS include grape juice, puffed snacks, mixed cereals (dry, multi-grain), dry rice cereals,
rice cereals prepared with water, and teething biscuits. Of the 384 samples collected for TDS, 65 percent of
associated analytical results for lead, arsenic, cadmium, and mercury had no detectable levels. Bottled water
intended for infants also did not have any detectable levels of lead, arsenic, cadmium, nor mercury. FDA believes
that the results suggest there are no significant regional or seasonal differences in analyte concentrations in foods
intended for babies.

FSIS Summarizes Foodborne

Illness Outbreak
Investigations for FY 2021
USDA's Food Safety and Inspection Service (USDA's FSIS) has published its annual report on FSIS Foodborne Illness
Outbreak Investigations for Fiscal Year 2021 (FY 2021). FSIS investigated nine total foodborne illness outbreaks in
FY 2021 compared to 16 in FY 2018, 16 in FY 2019, and 12 in FY 2020. Of the nine outbreaks that FSIS
investigated in FY 2021, seven were multi-state outbreaks. The nine outbreaks involved approximately 200
illnesses and 60 hospitalizations. Salmonella was associated with three of the nine outbreaks, and another three
outbreaks were linked to Shiga toxin-producing Escherichia coli (STEC). A single outbreak was associated with
Listeria monocytogenes. The ninth outbreak involved a suspected case of botulism, but neither botulinum nor
Clostridium botulinum were detected in the suspect beef product.

The Salmonella outbreaks comprised four serotypes—Hadar, Enteritidis, Typhimurium, and Infantis—and were
linked to turkey, chicken, and pork products; serotypes Typhimurium and Infantis were associated with the same
outbreak. The L. monocytogenes outbreaks were linked to chicken and multiple products. The STEC outbreaks
involved serotypes O157:H7 and O145, and beef was the most common food product linked to illnesses caused by
STEC in FY 2021. The outbreak investigations that occurred in FY 2021 led to three recalls and two public health
alerts.

In addition to summarizing its foodborne illness outbreak investigation activity in FY 2021, FSIS also highlighted
two key after-action reviews (AARs) in the report. The first AAR was conducted for an outbreak of Salmonella
Enteritidis that was associated with raw, frozen, breaded, and stuffed chicken products. The AAR's findings
prompted FSIS to bring certain concerns regarding labeling, establishments' food safety programs, and Salmonella
sampling in establishments to the National Advisory Committee on Meat and Poultry Inspections (NACMPI). FSIS
also encourages manufacturers to review FSIS Labeling Policy Guidance for Uncooked, Breaded, and Boneless
Poultry Products.

The second AAR was conducted for an outbreak of L. monocytogenes that was associated with ready-to-eat (RTE)
chicken. Whole genome sequencing (WGS) provided FSIS investigators with key data in the L.
monocytogenes outbreak investigation. FSIS encourages manufacturers of RTE products that are exposed to the
environment post-lethality to review the FSIS Compliance Guideline for Controlling L. monocytogenes.

EU Revises Regulations for

Ethylene Oxide in Food
Additives
The European Commission has recently published revisions to its regulation on the use of ethylene oxide in food
additives. The revisions have been made to provide clarity on the allowable levels of ethylene oxide present in
food additives, as uncertainty surrounding regulation of the substance has led to enforcement challenges and
recall incidents. Ethylene oxide is a chemical substance with many applications, such as the sterilization of raw
materials in food production. However, the substance has been identified as a carcinogenic, mutagenic, and
reproductive toxin.

Citing Rapid Alert System for Food and Food Network (RASFF) notifications, the European Commission explains
that there have been several recent incidents concerning the presence of ethylene oxide in food products from
food additives that contain the substances. The difficulty of discerning the source of ethylene oxide that is present
in foods—be it through the unlawful sterilization of food additives or any other reason—has made enforcement of
the substance in food challenging.

To avoid future enforcement challenges and recall incidents, the European Commission has clarified that the
presence of ethylene oxide, irrespective of its origin, is not authorized for all food additives. The Commission has
also set a limit of 0.1 mg per kg for ethylene oxide, including 2-chloro-ethanol expressed as ethylene oxide, in
certain additives that are treated with the substance.

FDA Extends Deadlines for

Agricultural Water Proposed Rule

The U.S. Food and Drug Administration (FDA) has issued a supplemental notice of proposed rulemaking that
extends the compliance dates for pre-harvest agricultural water provisions as outlined in the recent 2021
Agricultural Water Proposed Rule. The proposed rule, if finalized, will require farms to conduct annual, systems-
based agricultural water assessments to determine the necessary measures to minimize potential risks associated
with pre-harvest agricultural water.

FDA is now proposing extended compliance dates for the proposed pre-harvest requirements and is also providing
clarifying information about the enforcement discretion policy for the harvest and post-harvest agricultural water
requirements. The supplemental rulemaking proposes to establish the following compliance dates for the pre-
harvest agricultural water requirements for covered produce other than sprouts:

Two years and nine months after the effective date of a final rule for very small businesses

One year and nine months after the effective date of a final rule for small businesses

Nine months after the effective date of a final rule for all other businesses.

The 2021 pre-harvest agricultural water proposed rule did not set forth substantive changes to the harvest and
post-harvest agricultural water requirements in the Produce Safety Rule; however, FDA recognizes that prior to
the proposal, stakeholders did not have clarity on whether FDA might propose changes to the harvest and post-
harvest agricultural water requirements. The agency intends to continue enforcement discretion for the harvest
and post-harvest agricultural water requirements of the Produce Safety Rule until the following dates:

January 26, 2025 for very small businesses

January 26, 2024 for small businesses

January 26, 2023 for all other businesses.

For the first year of compliance, FDA intends to work closely with state, regulatory, and industry partners to
advance training, technical assistance, educational visits, and on-farm readiness reviews to prepare growers and
state regulators for implementing the provisions prior to initiating routine inspections to verify compliance.

For more information on the Proposed Agricultural Water Rule, please see our IAFP interview with Kruti Ravaliya,
M.S., Consumer Safety Officer in the Division of Produce Safety at FDA's CFSAN, as part of Food Safety Matters
podcast Episode 125.

Economic Impact of Biofilms on

Food Industry

A study published in Biofilms and Microbiomes has approximated the economic impact of biofilms on the food
industry. The study also describes the existing scientific and technological challenges that must be overcome to
progress in the areas of biofilm research and innovation. The study is based on a market analysis and exploratory
workshops that were conducted by the UK's National Biofilms Innovation Center (NBIC). According to the study,
biofilms cause an estimated $324 billion impact on the global agrifood sector, annually. For context, the world's
agricultural activity is valued at approximately $3,700 billion, and the annual economic impact of biofilms across
all sectors is estimated at $5,000 billion.

The study states that, at present, the main method for controlling biofilms in the food sector is through the use of
sanitation and hygiene practices in food processing facilities. Sanitation and hygiene are effective when properly
executed, although they can be expensive to implement and are subject to occasional failure. Additionally,
although the use of antibiotics in animal feed was once a popular method for mitigating microbial hazards at the
agricultural level, the practice is falling out of favor due to the growing threat of antimicrobial resistance (AMR).

When measures for combatting microbial hazards and biofilms fail, there can be a significant impact on human
health and a country's financial resources. The study provides an example of a UK foodborne illness outbreak that
originated from produce contaminated by Listeria monocytogenes, which cost the manufacturer €30 million ($35.1
million) in recall, transport, and destruction costs. The study also notes that, in the U.S., foodborne pathogens
cause approximately 128,000 hospitalizations each year, resulting in an economic impact of $78 billion, annually.

NBIC's exploratory workshops fostered knowledge-sharing between academics and industry representatives that
revealed many scientific and technological challenges that prevent innovation in controlling biofilms. The study
lists some of the key areas in which scientific knowledge and technological advancement are necessary, including:

Understanding the interaction between biofilms and various surfaces

Knowledge of the matrixome—a contributing factor to certain physiochemical attributes of biofilms—to

design more effective interventions

Rapid early detection systems for real-world applications

Improved biofilm analysis methods to deepen understanding of biofilm structure and function

Managing biofilms in natural environments

Understanding the mode of action of antimicrobials and antibiotics, as well as antimicrobial and antibiotic
interactions with biofilms

Improved models and standards for biofilm evaluation

Augmenting biofilm repositories and biobanks.

FDA Releases Pesticide Residue

Report for FY 2020

FDA has released its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2020 (FY 2020), which
reveals that the levels of pesticide residues measured by FDA in the U.S. food supply are generally in compliance
with the U.S. Environmental Protection Agency's (EPA's) pesticide tolerances. The report summarizes FDA's
findings from its monitoring of pesticide residues in human and animal foods in FY 2020.

The report is based on data that was collected from October 1, 2019 through September 30, 2020, during which
time FDA tested for approximately 750 different pesticides and selected industrial compounds on 2,078 human
food samples (316 domestic and 1,762 imported samples) in its regulatory monitoring program. Agency staff
collected domestic human food samples from 35 states and imported human food samples from 79 countries. FDA
states that the number of pesticides and industrial compounds analyzed in FY 2020 decreased slightly compared to
FY 2019, as compounds that are obsolete or are rarely detected were removed from the agency's scope.

In FY 2020, FDA found that 96.8 percent of domestic and 88.4 percent of imported human foods were compliant
with EPA pesticide tolerances. No pesticide residues were found in 40.8 percent of domestic samples and 48.4
percent of imported samples. Among the human food commodity groups, the violation rate in each group was
higher for import samples. FDA also analyzed 102 animal food samples (40 domestic and 62 imported samples) for
pesticides. The agency found that 100 percent of domestic and 96.8 percent of import animal food samples were
compliant with federal standards. No pesticide residues were found in 30 percent of domestic and 48.4 percent of
imported animal food samples.

Dairy Management Inc. has hired Lori Captain as Executive Vice President of Global Sustainability Strategy, Science, and Industry Affairs.
CAPTAIN

Michelle Danyluk, Ph.D., assumed the Presidency of the International Association for Food Protection (IAFP) at the conclusion of IAFP 2022.

The American Association of Meat Processors (AAMP) named Darla Kiesel its new President during AAMP's annual convention in 2022.

Kevin McAdams was appointed President of Perdue Foods and Chief Operating Officer of Perdue Farms.

MCADAMS

Joe Pezzini, Senior Director of Agricultural Operations for Taylor Farms, has been elected Chair of the Center for Produce Safety (CPS) Board of Directors.

Goodway Technologies announced that Michael Navaroli has joined the company as Vice President of North American Sales.
NAVAROLI

Standard Meat Company named Tom Allen as the company's new Chief Operating Officer.

TuffWrap Installations Inc., a supplier of dust and debris containment services, has appointed Daniel J. Schmidt as the National Sales Director.

Sokol Custom Food Ingredients has named Antonio Marungo as Director of Culinary Development and Innovation and promoted Max Pombert to
Director of Process Development and Commercialization.

PPG packaging coatings announced that Marcio Grossman's role as the PPG General Manager of Latin America South and Packaging Coatings Latin
America (LATAM) has expanded to include the U.S. and Canada (USCA) region. Benjamin Jo was promoted to PPG Senior Director of Global Packaging
Strategic Accounts. Jenica Eisenbach was named the new PPG global packaging Technical Service Director. Anurag Raj joined as the PPG Customer
Sustainability Business Partner, Packaging Coatings.

Arm & Hammer Animal and Food Production has added Greg Schafer as Food Safety Swine Account Manager.

AIB International Updates Consolidated Standards

for Inspections
The globally recognized AIB International Consolidated Standards for Inspections have been updated to incorporate the latest industry best practices, new
regulations, and food safety requirements. The updated consolidated standards were released on July 25, 2022, and inspections against the updated version
will begin January 1, 2023.

Major updates include moving written programs to the Adequacy section, dividing the Food Safety Programs standard into two separate standards for Hazard
Analysis and Critical Control Points (HACCP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC), expanding the Food Defense standard to
provide more guidance for a program that can be applied globally, and creating a separate Regulated Food Defense standard to meet the U.S. Intentional
Adulteration requirements.

In 2022, as part of AIB International's commitment to ensuring the integrity of the food supply chain, the company updated five of its Consolidated
Standards, including the Consolidated Standards for Prerequisite and Food Safety Programs, Beverage Facilities, Non-Food Contact Packaging Manufacturing
Facilities, Food Contact Packaging Manufacturing Facilities, and Food Distribution Centers. The remaining Consolidated Standards will be updated in 2023.

bioMérieux to Conduct Salmonella Quantification in

Poultry for FSIS
The U.S. Department of Agriculture's Food Safety and Inspection Service (USDA's FSIS) and bioMérieux have announced the incorporation of bioMérieux's
GENE-UP® QUANT Salmonella assay into the methodology used by FSIS regional laboratories. FSIS states that Salmonella quantification is part of the agency's
efforts to reduce Salmonella illnesses associated with poultry and to modernize FSIS laboratories' diagnostic capabilities. Using this new system, FSIS will be
able to measure the amount of Salmonella present in a regulatory sample, not solely its presence or absence.

Despite the many Salmonella interventions that have been developed over the last two decades, the incidence of Salmonella infections in humans has not
improved. Historically, the common method of Salmonella prevalence testing used by the agrifood industry has been a percentage-based approach focusing
on the safety of the final product. After evaluating commercially available quantification systems, FSIS determined that GENE-UP® QUANT Salmonella is the
most appropriate for sampling raw poultry rinses in its high-throughput laboratory environment. FSIS plans to extend pathogen quantification technology to
sample types other than raw poultry rinses in the future.

Intertek Alchemy Releases Findings from 7th

Global Food Safety Training Survey
Intertek Alchemy has published key findings from its seventh Global Food Safety Training Survey. The survey is a comprehensive study and assessment of
food safety training practices, drawing on responses from industry professionals representing more than 3,000 food production facilities worldwide. The
research reveals what actions and characteristics that companies with robust food safety programs have in common, and what actions the companies with
trailing outcomes lack. The report provides an extensive analysis that outlines actionable, data-driven recommendations to help manufacturing companies
strengthen their food safety processes.

Intertek Alchemy highlights significant challenges and contradictions of current food safety training practices that were revealed in its survey. For example, 88
percent of companies believe they provide adequate levels of food safety training to drive consistent and appropriate food safety behaviors; however, only 40
percent of their employees follow food safety programs on the manufacturing floor.

Other key findings from the survey include:

81 percent of companies understand what it takes to build and sustain a strong food safety culture, but only 22 percent strongly agree that their
employees have the authority to take action when food safety is compromised

80 percent of companies believe they would be more productive if their employees consistently adhered to their training programs; however, only 19
percent of companies are increasing their budget for food safety training, and only 18 percent plan to acquire new training technology in 2023

Tailoring training to specific job roles increases the likelihood by 60 percent that a frontline employee will halt production when necessary to prevent a
food safety incident

78 percent of companies with a mature upskilling program have highly motivated employees, compared to 43 percent for companies without an
upskilling program.

Safe Foods Begins Expansion Project

Safe Foods Corporation, a division of Packers Sanitation Services Inc. (PSSI), recently began a $14-million project designed to increase the range of products
Safe Foods can produce at its Little Rock, Arkansas headquarters. The construction of a new blending plant, including a new reactor and two storage tanks,
will double the production capacity for Safe Foods' organic food wash. The project also includes a new, 55,000-square foot packaging facility and warehouse
that will allow Safe Foods to manufacture 19 additional product lines for PSSI that will be used to protect consumers from foodborne illness. Plans also
include the renovation of a rail spur and new unloading stations.

AEMTEK Expands Services with New Location

AEMTEK, a food safety laboratory and analytical services provider, has opened a new location in Modesto, California. This facility will bring food safety testing
closer to current and future clients in California's Central Valley. The facility features state-of-the-art equipment to provide companies with routine food safety
testing, environmental monitoring testing and consultation, and research services including shelf life, challenge, and process validation studies. An
experienced team of Ph.D. scientists and microbiologists is excited to partner with food manufacturers of the Central Valley to help them achieve their food
safety goals and keep the community safe.

ONLINE & OF NOTE

FDA Releases New Dashboard for LAAF Program
A new Laboratory Accreditation for Analyses of Foods (LAAF) dashboard has been added to
the U.S. Food and Drug Administration (FDA) data dashboard to serve as the online public
registry listing for information on participants in the LAAF program. The functionality of
the LAAF dashboard includes searching; viewing; and the ability to export the lists of
recognized accreditation bodies, LAAF-accredited laboratories, and each laboratory's testing
scopes. Interested accreditation bodies may apply for recognition under the LAAF program
through an electronic portal. Interested laboratories may apply directly to one of the
recognized accreditation bodies to seek LAAF accreditation.

Allergen Bureau Launches Assessing Agricultural Cross-

Contact Guide for Industry
The Allergen Bureau has launched its new "Assessing Agricultural Cross-Contact 2022"
guide, which aims to assist agrifood businesses in mitigating allergen cross-contamination.
In addition to the guide, the Allergen Bureau's Sampling and Testing working group has
developed a questionnaire that industry can use to determine the level of risk that may be
associated with raw materials, as well as learn how the development of sampling plans can
be guided by risk and how facilities can discern the presence and prevalence of allergen
cross-contact. The guide, in conjunction with the raw material risk matrix questionnaire,
enables businesses to identify risks and take action. The risk rating can be used to inform
sampling approaches for verification activities to understand the presence and prevalence
of cross-contact. The new resource can also help the VITAL (Voluntary Incidental Trace
Allergen Labeling Program) risk assessment process.

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

REGULATORY REPORT
By Sharon Seelman, M.S., M.B.A., Biologist, Coordinated Outbreak Response and Evaluation Network (CORE), Center for Food Safety and Applied
Nutrition (CFSAN), U.S. FDA; Kari Irvin, M.S., Deputy Director, FDA CORE; Stelios Viazis, Ph.D., Consumer Safety Officer, FDA CORE; and Julia Mangia,
M.P.H., Health Communications Specialist, FDA CORE

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The Incident Command System

and Foodborne Illness Outbreak
Investigations
The Coordinated Outbreak Response and Evaluation
(CORE) Network is the coordination focal point for all
FDA resources during outbreak investigations
Image credit: valentinrussanov/E+ via Getty Images

The Basics of Foodborne Illness Outbreak Investigations

When a foodborne illness outbreak is detected, public health and regulatory officials work together to determine
what caused the outbreak and then take actions to avert additional illnesses from happening.1,2 During outbreak
investigations, public health and regulatory authorities collect three types of data to determine a common food
consumed by ill people: epidemiologic, traceback, and laboratory.

State and local partners, in collaboration with the Centers for Disease Control and Prevention (CDC), identify
outbreaks and the foods that may be causing the illnesses through public health surveillance and epidemiologic
evidence. State and local partners work with the U.S. Food and Drug Administration (FDA) to conduct traceback
investigations and examine the food supply chain to determine the origin of the foods identified by the
epidemiologic investigations.3 State and local authorities, in partnership with FDA, may use product and
environmental sampling, followed by laboratory analyses, to further confirm the identified food as the outbreak
source.

The data analyses and subsequent decision-making require extensive input from all investigation partners.
Through a combination of the data gathered during an investigation, a food may be implicated as the source of an
outbreak. FDA, CDC, and state and local partners work together to inform the public of outbreaks and provide
information on how the public can protect themselves from foodborne illness. Based on investigational data, FDA,
for example, may ask a firm to recall the product from the market or, in the case of imported products, may issue
an import alert to provide additional information to the field to help stop outbreaks and protect public health.

In a peer-reviewed article in the Journal of Emergency Management, FDA authors presented in detail the
organizational structure used to detect, respond, and follow up on foodborne illness outbreaks from the
perspective of FDA, and specifically how the Incident Command System (ICS) principles are used.4 Here, we look
at the benefits of using ICS principles during emergency response coordination activities for foodborne illness
outbreaks, with input from members of FDA's Coordinated Outbreak Response and Evaluation (CORE) Network.
ICS terminology and definitions can be accessed through resources from the Federal Emergency Management
Agency (FEMA), which provides a consistent nationwide template to enable partners to work together to prevent,
protect against, respond to, recover from, and mitigate the effects of incidents, regardless of cause, size, location,
or complexity.5

The Integrated Food Safety System and Outbreak Response Landscape

The collaboration and interactions between federal, state, and local partners during outbreak investigations are
directly impacted by federal, state, and local laws, including legal restrictions on sharing certain confidential
information, and the unique relationships between federal, state, and local agencies.6 Local or state agencies
conduct most investigations of foodborne illness outbreaks following their own policies and procedures, and serve
as the first responders to incidents that originate within their state.7 

In 2011, the Food Safety Modernization Act (FSMA) mandated the development of strategies to enhance food
safety that align with FDA's efforts to create and execute processes toward achieving a national integrated food
safety system (IFSS).8 An IFSS represents a partnership among federal, state, local, and territorial agencies to
achieve the public health goal of a safer food supply.8 One example of an integrated approach to food safety in
such a situation includes the 24 collaborative Rapid Response Teams (RRTs) across the country that plan, train,
and investigate outbreaks using ICS/National Incident Management System (NIMS) principles. These principles
guide government responses to incidents that threaten public health and safety.5,8,9,10 When it comes to
multistate outbreak investigations linked to FDA-regulated food products, CDC and FDA collaborate with the
states and the RRTs involved.

FDA CORE Organizational Structure

The FDA CORE Network was established in 2011 to coordinate outbreak surveillance, response, and post-response
activities related to incidents involving multiple illnesses linked to food and cosmetic products.2,4 The teams that
make up CORE include: Signals and Surveillance Team (SST), multiple CORE Response Teams (CRT), Outbreak
Evaluation Team (OET), Outbreak Analytics Team (OAT), and the Communications Team. The teams comprise
dedicated staff with multidisciplinary backgrounds, with all members focused on the protection of public health.

CORE is the coordination focal point for all FDA resources during foodborne illness outbreak investigations and
provides a platform for partners to share and evaluate information and facilitate decision-making.11 ICS allows for
the established organizational structure to be scalable, depending on the magnitude and complexity of the
outbreak. As the outbreak complexity increases, the structure may expand from the top down, and responsibilities
can be delegated accordingly.6 CORE uses ICS principles to respond to both large and small outbreaks, which
allows investigative partners to participate in a consistent process with well-established communication channels
and clearly stated outcomes.

“CORE is responsible for ensuring there is no duplication of

efforts. It does this by keeping all stakeholders informed of
investigational activities and the big picture."

And So, It Begins: Signals and Surveillance

An outbreak can be broken down to three phases: signals and surveillance, response, and post-response. "At
CORE, everything begins with signals," according to Jennifer Beal, the Team Leader for the SST. Signals consist of
emerging disease surveillance trends that the SST evaluates in collaboration with CDC, FDA field offices, and state
agencies. "My team focuses on early detection that will limit or prevent illness, by continuously evaluating data for
signals that an outbreak is potentially linked to an FDA-regulated product," Beal explains.

This early detection also involves weighing a combination of factors to determine whether an outbreak
investigation warrants the activation of a CRT for further coordination. Factors considered in this assessment may
include: FDA-regulated product identified as a suspect vehicle, pathogen/commodity pairing, vulnerable
population impacted, hazard severity, ongoing or growing outbreak, multistate illnesses, pathogen strain
commonality and history, product shelf life, required traceback, sampling, company investigations, coordination
between multiple internal and/or external partners, public messaging, and international significance.

An outbreak that requires extensive coordination is assigned to a CRT, and an alert notification is shared with
partners throughout FDA. This initiates the sequence of meetings that make up the Operational Period Planning
Cycle, also known as the Planning P, aimed at the development of an Incident Action Plan (IAP).4 According to
Jennifer Beal, "Most times, the signals we receive don't develop into outbreaks that require coordination at the
federal level, and sometimes incidents may be resolved without even activating a response team." Between CORE's
establishment in 2011 and December 2020, approximately 33 percent of incidents evaluated by the SST were
transferred to a CRT for further coordination.

CORE's Outbreak Response Operations and Use of ICS

According to Karen Blickenstaff, Response Staff Director of CORE, "Even though CORE does not deploy resources
to the field, it is responsible for establishing a national foodborne illness outbreak response strategy for FDA."
This charge led to CORE adapting the primary ICS roles as Incident Coordinator, Operations Section Chief,
Planning Section Chief, and Communications Specialist. FDA has also adapted the use of ICS forms, and of those,
CORE utilizes an IAP that comprises the ICS 201, ICS 202, and a modified ICS 209.

Through incident evaluation, CORE has identified these forms as the most relevant documents in communicating
FDA objectives to regulatory partners during outbreak investigations.12 The ICS 201 is developed by the SST to
provide pertinent information to CRTs and includes an epidemiologic map and summary, historical information
about the suspect vehicle and pathogen strain, proposed objectives and structure for an incident response,
background on preliminary traceback, sampling activities and firms of interest, and a point of contact list.
Consequently, ICS 202 is updated for each operational period, and a summary of completed tasks is included in the
general situational awareness section of the document.

Following the activation of a CRT, the response coordination is initiated, followed by organizing and analyzing
available information, and proposing the length of the operational period. Command and General Staff Meetings
are held to review information, set operational objectives, discuss tasks that need to be completed (including
laboratory and traceback investigations), allocate resources, and draft ICS documents. "This structure and flow of
operations removes the ambiguity and uncertainty that existed prior to adapting ICS to our specific outbreak
coordination needs," says Karen Blickenstaff.

The draft ICS 202 containing the proposed objectives for the upcoming operational period is shared with the
incident group, which encompasses all outbreak investigation partners, including CDC and relevant state officials,
during a CRT-led Tactics Meeting. During this Tactics Meeting, the objectives of the operational period are
presented, discussed, and revised as necessary. Investigational information is shared, including epidemiologic,
laboratory, and traceback investigation updates, as well as potential communication updates for the public.
Partners assist with completion of the overall objectives but develop their own tactics and plans according to their
resource availability and limitations.

CORE is responsible for ensuring there is no duplication of efforts. It does this by keeping all stakeholders
informed of investigational activities and the big picture. A Planning Meeting is held among CRT members to
adjust the objectives based on the information obtained from the Tactics Meeting and the information needed to
finalize the ICS 202. Finally, an Operations Briefing email is distributed to the entire incident group, thus
initiating the new operational period. "These documents have really helped CORE keep all our partners up to date
with the latest information available for each outbreak," says Karen Blickenstaff. "They've kept us organized and
focused on accomplishing our objectives for each operational period."

As an incident develops, the same sequence of meetings takes place for each operational period. "Partners know
what to expect for each outbreak, and we do our best to deliver on our promise for operational clarity and
transparency for each and every outbreak we collaborate with them on," says CORE Director Dr. Stic Harris. CORE
has adapted ICS to have operational periods that last days or weeks, depending on the rate at which information is
obtained, evidence is developed, illnesses are reported, and public health actions are taken.

Getting the Message Out: Public Communications

The Communications Team members are the Public Information Officers of an outbreak and communicate
important information, such as advice for the public, through various media platforms. This team is the focal point
for outbreak-related inquiries from, or outreach to, Congress, industry, and media. The Communications Team
collaborates with CDC, other federal agencies, and state, local, and international partners to coordinate
communication efforts. Between 2011, when CORE was established, and March 2021, the CORE Communications
Team issued 104 outbreak advisories and several subsequent updates, resulting in over 400 posts to the FDA.gov
website.

According to Corinne Newhart, the Team Leader for the CORE Communications Team, "Issuing public
communications aligns with CORE's mission to help control and stop outbreaks by providing the most relevant
and actionable information to the public in a timely manner." As part of the process outlined in the draft ICS 202,
investigation partners discuss any planned public communications for ongoing outbreaks to help ensure that all
public health messaging is strategic, accurate, and effective. Investigation partners also have an opportunity to
link to another agency or authority's public communications to help amplify a unified health message when
appropriate.

“CORE's adaptation of ICS principles has shown that a modular

and flexible system for all outbreak response efforts, regardless
of etiology, can be employed by any organization."

Examples of Outbreak Investigations and Use of ICS

In February 2020, federal, state, and local partners investigated an outbreak of Shiga toxin-producing Escherichia
coli O103 infections linked to contaminated clover sprouts.13 A total of 51 illnesses were reported from ten states.
CORE was engaged in the response of this incident for four months. The response phase included six operational
periods ranging from one day at the peak of activities to two weeks toward the end of the incident, completing at
least 24 unique objectives. In addition to the members of the CRT, the incident response group included
representatives from six different Center for Food Safety and Applied Nutrition (CFSAN) program offices, five
Office of Regulatory Affairs (ORA) headquarters offices, eight field offices, one ORA laboratory, CDC, and five
different state departments of health or agriculture and their respective laboratories. Federal, state, and local
partners conducted epidemiologic and traceback investigations that identified clover sprouts as the source of this
outbreak, while the analysis of a clover sprout sample yielded the outbreak strain. This led to a recall of the
product in February 2020, as well as FDA issuing a warning letter. CORE Communications issued five web postings
to advise the public to discard and avoid eating the recalled clover sprouts.

In March 2020, federal, state and local, and international partners investigated an outbreak of Listeria
monocytogenes infections linked to contaminated enoki mushrooms imported to the U.S. from the Republic of
Korea.14 A total of 36 illnesses were reported from 17 states. The response efforts of this incident lasted
approximately two months and included seven operational periods ranging from seven days at the peak of
activities to two weeks toward the end of the incident. In addition to the members of the CRT, the incident
response group included collaboration from five CFSAN program offices, seven ORA headquarters offices, 17
district offices (15 plus two import divisions), two ORA laboratories, CDC, 17 state departments of health and/or
agriculture and their associated laboratories, and public health and regulatory authorities from France, Australia,
and Canada.

CORE coordinated activities for seven operational periods, establishing more than 18 objectives. Epidemiologic
and traceback investigations identified the supply of enoki mushrooms from a single distributor sourced from a
single grower in the Republic of Korea, which led to a recall in March 2020. Sample collection and analysis
resulted in the recovery of L. monocytogenes isolates from 17 (five FDA, three state, nine foreign) samples and
yielded the outbreak strain. CORE Communications issued six web posts to announce updates in the investigation
and information about the vehicle linked to illnesses, to link to the firm's recall announcement regarding recalled
enoki mushrooms, and to provide actionable advice for consumers who may have purchased the product associated
with the L. monocytogenes clinical cases. This was the largest L. monocytogenes outbreak linked to enoki
mushrooms that affected multiple countries.

These two examples illustrate the complications and intricacies of responding to foodborne illness outbreaks from
a resource management and communications flow standpoint. They also showcase the benefits of adopting ICS
principles. "ICS affords us the ability to coordinate across multiple jurisdictions, maintain rapid information flow,
ensure accurate data transmission, communicate key findings, and develop reliable public messaging," says Alvin
Crosby, Supervisory Consumer Safety Officer and a CRT Team Leader. "While these two outbreaks overlapped
temporally, the flexibility afforded by CORE's multiple CRTs, as well as the ICS structure, allowed FDA to respond
to both outbreaks without resource capacity strain."

What Does ICS do for CORE?

CORE's adaptation of ICS principles has shown that a modular and flexible system for all outbreak response
efforts, regardless of etiology, can be employed by any organization.15 ICS has resulted in many benefits to the
operational cycle of outbreak response.4 CORE has been able to provide a reliable, consistent, and transparent
approach to outbreak investigations. Federal, state, and local partners participate in ICS meetings and receive
consistent outcomes at set periods of time.

According to Dr. Michael Bazaco, an epidemiologist with the OAT, "ICS has been instrumental in refining CORE's
outbreak coordination capacity, operating as a forum for laboratory, traceback, and epidemiologic evidence
sharing, data analysis, and decision-making. This allows partners to determine next steps through consensus,
confidently deploy and leverage resources, and take the necessary regulatory and public health actions."

Outbreak response efforts require a flexible approach when dealing with evolving situations, and ICS allows CORE
to use a framework that provides consistent but flexible operational functions. CORE can respond to multiple
concurrent outbreaks and, if needed, increase its capacity to respond to an expanding number of outbreaks
irrespective of magnitude or complexity.

References

1. U.S. Centers for Disease Control and Prevention (CDC). "Investigating Outbreaks." 2016.
https://www.cdc.gov/foodsafety/outbreaks/investigating-outbreaks/index.html.

2. U.S. Food and Drug Administration (FDA). "About the CORE Network." 2020. https://www.fda.gov/food/outbreaks-foodborne-illness/about-
core-network.

3. Irvin, K., S. Viazis, A. Fields, S. Seelman, K. Blickenstaff, E. Gee, M. Wise, K. Marshall, L. Gieraltowski, and S. Harris. "An Overview of Traceback
Investigations and Three Case Studies of Recent Outbreaks of Escherichia coli O157:H7 Infections Linked to Romaine Lettuce." Journal of Food
Protection 84, no. 8 (2021): 1340–1356. https://pubmed.ncbi.nlm.nih.gov/33836048/.

4. Seelman, S., S. Viazis, S. P. Merriweather, T. C. Cloyd, M. Aldridge, and K. Irvin. "Integrating the Food and Drug Administration Office of the
Coordinated Outbreak Response and Evaluation Network's Foodborne Illness Outbreak Surveillance and Response Activities with Principles of
the National Incident Management System." Journal of Emergency Management 19, no. 2 (2021): 131–141. https://doi.org/10.5055/jem.0567.

5. U.S. Federal Emergency Management Agency (FEMA). "National Incident Management System." 2017. https://www.fema.gov/emergency-
managers/nims.

6. Council to Improve Foodborne Outbreak Response. "Guidelines for Foodborne Disease Outbreak Response." 2020.
https://cifor.us/downloads/clearinghouse/CIFOR-Guidelines-Complete-third-Ed.-FINAL.pdf.

7. CDC. "National Outbreak Reporting System Guidance." 2017. https://www.cdc.gov/nors/downloads/guidance.pdf.

8. FDA. "National Integrated Food Safety System (IFSS) Programs and Initiatives." 2019. https://www.fda.gov/federal-state-local-tribal-and-
territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives.

9. Pierquet, Jennifer, Jessica Badour, Ernie Julian, Alida Sorenson, and Brian Sauders. "Creating the Rapid Response Road Map: Collaboration
Points the Way Forward." 2015. https://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2015/creating-the-rapid-response-
road-map-collaboration-points-the-way-forward/.

10. Pierquet, Jennifer, Jessica Badour, Ernie Julian, Alida Sorenson, and Brian Sauders. "Where the Rubber Meets the Road: RRTs in Action." 2015.
https://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2015/where-the-rubber-meets-the-road-rrts-in-action/.

11. Viazis, S., J. K. Beal, C. Monahan, W. A. Lanier, K. R. Kreil, D. C. Melka, W. D. Boden, J. L. Dion, Z. A. Miller, T. A. Nguyen, L. B. Gieraltowski, and D.
L. Zink. "Laboratory, Environmental, and Epidemiologic Investigation and Regulatory Enforcement Actions in Response to an Outbreak of
Salmonella Bredeney Infections Linked to Peanut Butter." Open Forum Infectious Diseases 2, no. 3 (2015).
https://academic.oup.com/ofid/article/2/3/ofv114/2460477.

12. FDA. "FDA Incident Command System (ICS) Forms." 2018. https://www.fda.gov/emergency-preparedness-and-response/national-incident-
management-system-implementation/fda-incident-command-system-ics-forms.

13. FDA. "Outbreak Investigation of E. coli O103: Clover Sprouts (February 2020)." 2020. https://www.fda.gov/food/outbreaks-foodborne-
illness/outbreak-investigation-e-coli-o103-clover-sprouts-february-2020.

14. FDA. "Outbreak Investigation of Listeria monocytogenes: Enoki Mushrooms (March 2020)." 2020. https://www.fda.gov/food/outbreaks-
foodborne-illness/outbreak-investigation-listeria-monocytogenes-enoki-mushrooms-march-2020.

15. Briggs, S. M. "Regional interoperability: making systems connect in complex disasters." The Journal of Trauma and Acute Care Surgery 67: S88-90
(2009). https://journals.lww.com/jtrauma/Abstract/2009/08001/Regional_Interoperability__Making_Systems_Connect.6.aspx.

Sharon Seelman, M.S., M.B.A., is a Biologist in the Coordinated Outbreak Response and Evaluation Network (CORE) at FDA's Center for Food Safety and
Applied Nutrition (CFSAN).

Kari Irvin, M.S., is the Deputy Director at FDA CFSAN's CORE Network.

Stelios Viazis, Ph.D., is a member of FDA CFSAN's CORE Network and part of the CORE Outbreak Analytics team.

Julia Mangia, M.P.H., is a Health Communications Specialist at FDA CFSAN's CORE Network.

BACK TO CONTENTS

FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

SANITATION
By Hal King, Ph.D., Managing Partner, Active Food Safety

Sanitation Prerequisite Programs

SCROLL DOWN

as a Necessary Component of
FSMS for Foodservice
Establishments
It is imperative that a paradigm shift happens now in
Image credit: NoSystem images/E+ via Getty Images
how risk is managed in foodservice establishments

Foodservice establishments continue to cause the greatest number of foodborne illness outbreaks (approximately
60 percent) every year among all causes of foodborne outbreaks in the U.S. When I published the first article on
the need for foodservice establishments to focus on achieving active managerial control of food safety risk in
2016,1 I reported then that 60 percent of all foodborne disease outbreaks in the U.S. were caused by foodservice
establishments [as reported then by the U.S. Centers for Disease Control and Prevention (CDC)].

Today, when you look at the most currently available data (2020) on the number of foodborne disease outbreaks
caused per year by foodservice establishments,2 nothing has changed. According to this data, there were 184
outbreaks (out of 299 total = 61 percent), 3,074 illnesses, 337 hospitalizations, and three deaths caused by
foodservice establishments in one year.

A Paradigm Shift is Needed

Traditionally, the foodservice industry has relied on checklists that require employees
to verify that they have performed certain actions—for example, checking the
temperature of food. These checklists often include other, nonspecific, related actions
to control only some hazards associated with food preparation. Although following
these checklists certainly helps reduce some foodborne illnesses and outbreaks, unless
each hazard associated with the prepared menu is identified and matched to the proper
control of that hazard, many hazards will be missed, leading to a continuation of
sporadic foodborne illnesses and outbreaks in this industry.

FSMSs based on HACCP are Key to this Paradigm Shift

The most effective FSMSs are based on the development of a Hazard Analysis and Critical Control Points (HACCP)
plan called Process HACCP, which is HACCP tailored specifically for foodservice establishments. This process
approach to HACCP is recommended by the FDA Food Code to assist foodservice establishments in achieving
active managerial control of food safety risk.4,5 It also includes the need for a PRP to define and control potential
hazards (using the FSMS) associated with sourcing safe ingredients, cleaning and sanitation, employee health,
hand hygiene, and other common food processes that occur in a foodservice establishment.

A Process HACCP plan is designed by first defining the flow of food preparation in a kitchen (like the flow of food
in a manufacturing facility production line) for all products prepared and sold on a restaurant's menu (Figure 1).
Each recipe/procedure (menu item) is defined that involves sourcing ingredients, receiving and storing
ingredients, preparing ingredients (e.g., thawing, marinating, cooking), and serving menu items, to determine if
potential hazards exist at each process. An example of a hazard is Salmonella or Clostridium perfringens on raw
chicken, which can contaminate hands/gloves and food contact surfaces. These hazard controls at each process
(Figure 1) can either be a Critical Control Point, or CCP (e.g., cooking the chicken to 165°F) and/or a Prerequisite
Control Point, or PCP (e.g., ensuring that areas where raw chicken is prepared are properly cleaned and sanitized,
and that employees wash hands and wear gloves properly after handling raw chicken).

FIGURE 1. The flow of food preparation processes common in all foodservice establishments, which is used to develop a Process HACCP plan based on the menu of the business (source: FDA 2017). Note the example PCPs
and CCPs of a menu item that would be monitored at each process step to ensure that the controls are present.

Multiple unique and different hazards can be associated with one or more process steps to prepare just one menu
item in a foodservice establishment, as there can be one common hazard associated with all of the process steps in
the preparation of all menu items (e.g., employees working when sick with Hepatitis A or norovirus). Every
foodservice establishment performs one or more of the same eight primary food preparation processes in common
for all menu items prepared and served to customers (Figure 1), regardless of what the menu items are, so this is
not as daunting as it may sound. For example, some foodservice businesses may not perform every process (e.g.,
they may not cool down and then reheat foods), but all will follow the same flow of food processes, and often
perform additional activities or not perform others based on the recipe and menu (e.g., limited-time offerings may
require cook, cool, and reheat processes not normally used in the regular food preparation plans for the menu, or
the business may remove menu items). The literature contains more information on how to develop a Process
HACCP plan for foodservice.5

Need for a PRP to develop the most effective FSMS

As discussed above, not all controls in a Process HACCP plan are CCPs in the flow of food processes, but they may
include important control measures found in the PRP. These are referred to as Prerequisite Control Points (PCPs)
to differentiate them from CCPs, but they are equally important. PCPs are derived from elements of a predefined
PRP. These elements define activities that may introduce additional hazards (e.g., cross-contact of allergens in the
kitchen) that are not defined by the Process HACCP plan. The minimum recommended components of a PRP
necessary for an effective FSMS in a foodservice operation include:

Methods to ensure equipment maintenance

Equipment to ensure temperature measuring devices are calibrated

Cooking equipment is calibrated, and hot and cold holding equipment provides the correct temperature

Refrigeration and freezer equipment provides the correct environmental temperature to keep prepared
foods at the correct internal temperature

Ware washing equipment is operating according to manufacturer's specifications.

Methods to ensure allergen management and control in food preparation and storage (in relation to customer
avoidance messaging, if any)

Methods to ensure safe chemical use and storage around foods, and employee safety that meet Occupational
Safety and Health Administration (OSHA) requirements for foodservice businesses6

Methods to ensure safe water use for food and in the manufacture of ice

An effective pest prevention program to prevent pest infestations

Methods to ensure no bare-hand contact with any ready-to-eat (RTE) food to prevent the cross-contamination
of food from hands, and where handwash sinks should be located to facilitate

Methods to ensure proper handwashing to prevent the cross-contamination of foods from hands, including
when wearing gloves

Methods to ensure restriction and exclusion of sick employees who have known signs, symptoms, or diagnosis
of foodborne illnesses to prevent the cross-contamination of foods from hands, including cuts and burns7

Personal hygiene requirements of employees (clean clothing, hair restraints, eating/smoking/drinking

restrictions, jewelry restrictions)

A cleaning and sanitation component for the direct prevention of cross-contamination of RTE foods by raw
animal foods, how to clean and sanitize food-contact surfaces, cutting boards, dishware and dishwashing
equipment, utensils, floors, and high-touch surfaces

Methods to ensure safe sources of foods using only food-safe ingredient and packaging suppliers (e.g., GFSI
and FDA FSMA compliant supplier food manufacturing facilities; meet requirements for FDA food packaging
in contact with food)

Methods to ensure ingredients are not used past their safe expiration date, using first-in first-out (FIFO) (e.g.,
date marking and execution)

Methods to ensure that if an ingredient/food product in use has been recalled by FDA, an approved supplier,
or by a CDC "do not consume" communication, the restaurant is alerted and takes action to remove the
ingredient product from prep, storage, and service.

In fact, these last three points (FIFO and use of approved sources of foods/packaging) in a PRP will help manage
the critical foodborne illness risk factor of unsafe ingredient and food sources. When this factor is not under
control, it can increase the number of potential hazards in all other food preparation processes; this has led to
many foodborne illness outbreaks from foodservice establishments, even when the source of food was safe when
ordered but became unsafe after it was recalled, and the business was not aware of the recall.

Many multi-unit retail foodservice businesses have established supply chain management programs to ensure that
each facility/location uses approved sources of food ingredients and products vetted by corporate program
specifications. A foundation of these specifications should be a supplier's compliance to FDA's FSMA rules to
manufacture human foods.8 One of the first elements that a supply chain management program should include is a
review of and expectation that all suppliers have developed a food safety plan for each product, and that high-risk
products are monitored to ensure execution of this FDA requirement. For more details on how a foodservice
business can develop a supply chain food safety management program based on FDA FSMA rules, see the
literature.9

“Sanitation within the Prerequisite Program plays a key role in

the prevention of foodborne illnesses and outbreaks, including
the prevention of allergens.”

PRPs Must Include a Detailed Sanitation Component

One of the most important elements of a PRP is the sanitation procedures, training of employees and managers,
and evidence for proper execution in the FSMS. Sanitation within the PRP plays a key role in the prevention of
foodborne illnesses and outbreaks, including the prevention of allergens. Establishing and monitoring PCPs in the
FSMS of each facility is critical. The CDC lists 30 contributing factors that lead to the majority of foodborne illness
outbreaks in the categories of contamination of hands/gloves and surfaces, proliferation of pathogens, and
survival of pathogens.10 A study by CDC of 114 foodborne disease outbreaks reported to the National
Environmental Assessment Reporting System (NEARS) showed that contamination of hands and surfaces (via
cross-contamination) attributed to 81 percent of outbreaks investigated,11 showing just how important
foodservice sanitation is in the prevention of foodborne illnesses.

FDA's Food Code and most state regulatory foodservice facility plan review documents include requirements for
the cleanability of surfaces including floors (and grout between tiles), walls, ceilings, food prep tables, food
contact surfaces, sinks, etc. They also include restrictions on some surface types, such as floor carpeting.
Equipment (ANSI-certified) placement in the design is also critical to ensure cleanability, especially where the
surface meets the walls or other equipment/tables. Environmental surfaces in a foodservice establishment can
harbor food debris, which can lead to the development of biofilms or biological hazards (e.g., Listeria
monocytogenes can produce a biofilm on stainless steel surfaces and then grow to larger numbers of bacteria on the
surface).

All surfaces must be accessible and cleanable, and the cleaning and sanitizing to remove all biological (e.g.,
microbial pathogens) and chemical (e.g., allergens) hazards, even if not a food contact surface, should be included.
If these surfaces are neglected, they can lead to cross-contamination as the biofilms accumulate and are released
on food contact surfaces or touched by employees that can then transmit the biofilms to other food preparation
surfaces or food. Floors and equipment on floors are one of the top areas in a restaurant for the persistence of
pathogens, and improper use of reusable mops and mop water may contribute to this risk. Pathogens like
Salmonella, Listeria, and norovirus can easily cross-contaminate other surfaces during body fluid cleanup
procedures, when aerosolized from employees walking on floors, the movement of wheels on carts, and during the
mopping procedure. One of the largest protracted outbreaks (from 2008–2019) in a restaurant was due to
persistent Salmonella in the restaurant found on numerous environmental surfaces.12 Thus, improper sanitation
of floors and drains can contribute to the spread of pathogens that lead to foodborne illness outbreaks.

Another important sanitation design requirement is to ensure proper cleaning, sanitation, and location of the
utility sinks and mop storage. Since these sinks are used for preparing chemicals for cleaning and/or storing
cleaning tools and chemicals, they should be located away from food storage, prep, and customer service areas. If
it is necessary that the sinks be located inside the kitchen area, then they should be "guarded" by splash guards
that prevent splashing of any solution or chemicals onto other surfaces, especially clean dishware, handwash
sinks, and food prep areas.

Dishware sanitation is important to include in the sanitation component of a PRP, and includes the storage and
washing area surface sanitation, as well as the racks and shelving used to separate and store clean dishware from
dirty dishware. Dirty dishware cleaning and storage areas must be adequately separated from clean dishware, and
adequate space must be available for drying dishware. Otherwise, a single cross-contamination event may arise
due to stacking wet dishware. For example, if a dirty container that held raw chicken comes into contact with a
clean container that will later be used to store prepared RTE chicken salad, this could easily cause a large outbreak
of foodborne illnesses. A best practice is to design the clean dishware storage area with racks and slots that will
accommodate every individual clean dishware item to drip dry without stacking.

When I first started leading food safety management at a large foodservice business enterprise (my first
experience working in the food industry after a career in public health for infectious disease prevention), I noticed
that many of the chemicals we were using at that time did not kill or eliminate foodborne pathogens, according to
their product descriptions and certification labels. The few chemicals that did have efficacy (via EPA registration
for efficacy and safety on food contact surfaces) available to the food industry required more than ten minutes of
contact time to achieve efficacy against microbial surrogates of foodborne pathogens. I remember asking several
of my chemical suppliers why they did not make a sanitizer that killed norovirus or Listeria, to which they did not
have an answer. Things have changed now for the better, but there is still an impulse to choose the lowest-cost
sanitizer without regard to its efficacy (contact times too long to feasibly kill any of the foodborne pathogens on
surfaces when used in foodservice).

To ensure sanitation, sanitizers should be selected that include these attributes:

The sanitizer is food contact surface safe (rinse or no rinse)

The sanitizer is safe to use by employees (according to OSHA requirements13)

Bleach-containing products can emit toxic fumes when used around some detergents

The sanitizer is effective against all major foodborne pathogens, including norovirus

The sanitizer is effective against these pathogens after short contact times (too much time reduces
compliance; the preference is less than 30 seconds)

The sanitizer remains effective during storage

Know if a cleaner or detergent is needed to clean a surface before sanitizing it (some sanitizers clean
and sanitize)

Some cleaners leave residue on surfaces.

An important element of the sanitation component of a PRP is the proper use of cleaning tools by employees.
Separate cleaning and sanitation tools (color-coded to indicate use) are commonly used in food manufacturing
facilities to prevent the cross-contact of allergens from one area to another and/or the cross-contamination of
food processing equipment between raw and RTE processing equipment. It is especially important to segregate
cleaning tools used for restrooms in foodservice environments from all other cleaning tools because hazards such
as norovirus and Hepatitis A are transmitted to surfaces in restrooms, where they can be "moved" from these areas
to kitchen surfaces.14 Likewise, using reusable cloth towels to clean surfaces and storing these towels incorrectly
can transmit hazards like Salmonella from raw chicken prep surfaces to food contact surfaces.15 

PRPs Must Define the Controls (PCPs) in the FSMS

As a PRP is critical to the safe preparation and service of food, the FSMS must include the establishment and
inclusion of the controls of each PCP, its critical limits, and a means to monitor the control, as is also done with
the Process HACCP defined CCPs at each process (Figure 2). To ensure that the PRP elements (especially the
sanitation requirements) are implemented into the FSMS, define each SOP and its related PCP to control the
hazard(s), ensure that employees are trained on their proper execution, and check the PCPs regularly during
operations. For example, the FSMS should define when employees must wear single-service gloves when handling
RTE foods, and provide the necessary training of employees and managers trained on how to monitor the proper
use of gloves.16 This training must include corrective actions for when managers observe an employee not using
gloves properly, to prevent cross-contamination of foods during the food prep processes.

FIGURE 2. Example use of PCPs defined in the PRP and CCPs defined in the Process HACCP plan. The Process HACCP and the PCP together define the hazards and their priority control measures that must be performed
during each step of each food preparation process (source in part: FDA 2017). Some PCPs may be assessed outside of the food preparation processes (not shown).

Each of these PCPs and the proper controls within a FSMS are discussed in more detail in the literature.5 The
hazards that can occur without determining PCPs and their controls (e.g., an employee working while sick with
norovirus, not wearing single-use gloves when handling RTE foods, surfaces not sanitized properly, etc.) can lead
to even larger foodborne disease outbreaks than a single missed CCP control, such as not cooking a single chicken
breast properly during the food prep process (which likely would make only one customer sick). Both controls are
important, of course, and this is why the FSMS must include PCPs specific to personal hygiene and other controls
within the PRP, including sanitation PCPs.

FSMSs with the Proper PRPs to Prevent Foodborne Outbreaks

In a study performed by FDA using FDA inspections of restaurants across the U.S., the restaurants that developed
and executed a FSMS by a Certified Food Safety Manager (e.g., ServSafe certified) had the lowest number of
foodborne illness risk factors.17 These procedures, collectively termed the PRP when used along with the Process
HACCP plan (Figure 3) to develop a FSMS, provide for the most comprehensive means for controlling all hazards
associated with foodservice business.

FIGURE 3. How the Process HACCP plan plus the PRP are used to create a FSMS. After the hazards have been identified in the food preparation processes used to serve the menu and in the PRP, and the controls have been
identified that must be in place to prevent the hazards, then the FSMS is developed to enable training of employees and the foodservice business to monitor the controls and take appropriate action to ensure that each is in
place.  

The primary reason a FSMS is so effective is because it uses a strong foundation of HACCP in the identification of
hazards in all food preparation processes of any menu, and it includes a requirement to identify and address
additional hazards that occur during basic operational procedures in a foodservice business. If all foodservice
businesses implemented a FSMS using these methods, it would guarantee a paradigm shift of fewer foodborne
illnesses and outbreaks in the U.S. every year, and the value of these businesses would likely increase.

References

1. King, Hal. "Implementing Active Managerial Control Principles in a Retail Food Business." Food Safety Magazine February/March 2016.
https://www.food-safety.com/articles/6212-implementing-active-managerial-control-principles-in-a-retail-food-business.

2. U.S. Centers for Disease Control and Prevention (CDC). "National Outbreak Reporting System (NORS)." February 3, 2022.
https://wwwn.cdc.gov/norsdashboard/.

3. King, Hal. "Off-Premises Dining Safety in the Restaurant and Foodservice Business." Food Safety Magazine June/July 2021. https://www.food-
safety.com/articles/7201-off-premises-dining-safety-in-the-restaurant-and-foodservice-business?oly_enc_id=9496I3331167H7N.

4. U.S. Food and Drug Administration (FDA). "Food Code 2017: Annex 4." March 7, 2022. https://www.fda.gov/food/fda-food-code/food-code-
2017.

5. King, Hal. Food Safety Management Systems. Springer (2020). https://doi.org/10.1007/978-3-030-44735-9.

6. U.S. Department of Labor, Occupational Safety and Health Administration (OSHA). "Safety and Health Topics: Young Workers—Restaurant
Safety." https://www.osha.gov/young-workers-restaurant-safety.

7. FDA. Retail Food Protection: Employee Health and Personal Hygiene Handbook. March 7, 2022. https://www.fda.gov/food/retail-food-
industryregulatory-assistance-training/retail-food-protection-employee-health-and-personal-hygiene-handbook.

8. FDA. "Food Safety Modernization Act (FSMA)." June 9, 2022. https://www.fda.gov/food/guidance-regulation-food-and-dietary-

supplements/food-safety-modernization-act-fsma.

9. King, Hal and Wendy Bedale. Hazard Analysis and Risk-Based Preventive Controls. Elsevier (October 2, 2017).
https://www.elsevier.com/books/hazard-analysis-and-risk-based-preventive-controls/king/978-0-12-809475-4.

10. CDC. Environmental Health Services. "Contributing Factor Definitions." January 31, 2022. https://www.cdc.gov/nceh/ehs/nears/cf-
definitions.htm.

11. CDC. "CDC's National Environmental Assessment Reporting System (NEARS): 2015 Summary Report."
https://www.cdc.gov/nceh/ehs/nears/docs/2015-nears-report.pdf.

12. Nettleton, William D., Bethany Reimink, Katherine D. Arends, Douglas Potter, Justin J. Henderson, Stephen Dietrich, and Mary Franks.
"Protracted, Intermittent Outbreak of Salmonella Mbandaka Linked to a Restaurant—Michigan, 2008–2019." CDC Morbidity and Mortality Weekly
Report. August 20, 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7033a1.htm.

13. OSHA. "Young Worker Safety in Restaurants eTool." https://www.osha.gov/etools/young-workers-restaurant-safety.

14. King, Hal. "Breaking the Chain of Infectious Disease Transmission in a Retail Foodservice Business." Food Safety Magazine August/September
2020. https://www.food-safety.com/articles/6750-breaking-the-chain-of-infectious-disease-transmission-in-a-retail-foodservice-business.

15. King, Hal. "Is It Time to Change How We Clean and Sanitize Food Contact Surfaces with Reusable Wiping Towels?" Food Safety
Magazine August/September 2018. https://www.food-safety.com/articles/6660-is-it-time-to-change-how-we-clean-and-sanitize-food-contact-
surfaces-with-reusable-wiping-towels.

16. King, Hal. "The Need for a Glove-Use Management System in Retail Foodservice." Food Safety Magazine June/July 2019. https://www.food-
safety.com/articles/6258-the-need-for-a-glove-use-management-system-in-retail-foodservice.

17. FDA. "Factsheet: The Occurrence of Foodborne Illness Risk Factors in Fast Food and Full-Service Restaurants 22013–2014."
https://www.fda.gov/media/117510/download.

Hal King, Ph.D., is Managing Partner of Active Food Safety, www.activefoodsafety.com, and a member of the Editorial Advisory Board of Food Safety
Magazine. He can be reached at halking@activefoodsafety.com.

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

TESTING
By Dave Stone, Ph.D., Professor of Food Science and Technology, Oregon State University; and Jason Sandahl, Ph.D., Founder, Ag Aligned Global
SCROLL DOWN

Demystifying Pesticide Residues  

To determine acceptable pesticide residue risk levels,
we rely on a risk assessment framework to make
science-based decisions
Image credit: MaYcaL/iStock / Getty Images Plus via Getty Images

Pesticide residues are an important and often controversial issue in the food industry. In the U.S., pesticides are
defined as a substance or mixture that is intended to prevent, destroy, repel, or mitigate any pest. Pesticides are
used throughout conventional and organic agriculture and play a critical role in controlling public health,
economic, and nuisance pests in many settings, spanning from pre-harvest use in crops to packinghouses,
transportation, retail, and restaurants. Pesticides also range widely in their toxicity, requiring a high degree of
regulatory structure for approval in the marketplace. This article covers how residue levels are regulated in the
U.S., who regulates them, the global scientific framework for trade, and how residues fit into food safety regimes.

Pesticide applications can leave trace chemical levels, called residues, in raw or processed foods. Typically, residue
levels range from non-detectable to parts per million. Since we intentionally apply pesticides to our food supply, a
system has been established over decades to determine an acceptable level of residue that does not pose an
unreasonable risk to consumers. This acceptable level depends on toxicity, type of food consumed, application
method, and several other factors. In some cases, certain pesticides are deemed to be unsuitable for use on human
food and animal feed because they pose an unacceptable risk to consumers, farmworkers, animals, or the
environment.

To determine acceptable risk levels, we rely on a risk assessment framework to make science-based decisions.
From this process, we ultimately develop a maximum residue level (MRL), also called a tolerance in the U.S.
According to the Food and Agricultural Organization of the United Nations (FAO), an MRL is the maximum
concentration of a pesticide residue to be legally permitted in food commodities and animal feeds. The MRL is not
a safety limit; rather, it is a regulatory tool as outlined in the following section.

“FDA can deem a food or feed to be adulterated if a pesticide

residue is found at greater levels than the tolerance, or if
pesticide residue is detected for which there is no established
tolerance or tolerance exemption.”

Regulating Pesticide Residues

In the U.S., several federal agencies and authorized state or tribal agencies have a role in regulating pesticide
residues. Initially, pesticides are registered by the Office of Pesticide Programs in the Environmental Protection
Agency (EPA) through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As part of the registration
process, EPA requests data from the registrant covering a wide range of issues from environmental fate to
formulation of the product. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes EPA to set a tolerance
on how much pesticide will remain on food or feed. This information is often based on field trials that test pre-
harvest intervals, application rates, varying environmental factors, and other relevant parameters. EPA then
evaluates several consumer, environmental, and occupational risks, including the use of dietary consumption
models to estimate exposure. If food tolerances are developed for a pesticide use on a specific food, then EPA will
publish notices for comment in the Federal Register. EPA can also make the determination that a pesticide or use is
exempt from the requirement for a tolerance.

While EPA develops the tolerance, the U.S. Food and Drug Administration (FDA) is responsible for enforcing the
tolerances for interstate commerce, as well as the import for all fruits and vegetables, most seafood, dairy, most
processed foods, and most egg products. Through the FFDCA, FDA can deem a food or feed to be adulterated if a
pesticide residue is found at greater levels than the tolerance, or if pesticide residue is detected for which there is
no established tolerance or tolerance exemption. These products are subject to seizure by the government. FDA
applies these rules equally to domestically produced and imported food and feed. Therefore, it is important that
countries that wish to export to the U.S. understand the country's regulations and framework. Similarly, it is
paramount that U.S.-based companies understand the tolerances, or MRLs, that exist in other countries when
exporting raw and processed products.

Monitoring programs are implemented to obtain data to determine if pesticides residues are in compliance with
MRLs. Monitoring results help determine if modifications to pesticide registrations are needed, possibly requiring
additional research. The data also serves to plan future monitoring activities for both domestic and imported food.
Ideally, the selection of commodities, frequency and number of samples should be based on risk and informed by
prior studies. FDA has been publishing residue monitoring reports since 1987. In 2020, FDA found that 96.8
percent of domestic and 88.4 percent of imported foods were compliant with federal standards. Furthermore, they
detected no pesticide residues in 40.8 percent and 48.4 percent of domestic and imported samples, respectively.

The U.S. Department of Agriculture (USDA) is responsible for monitoring residue levels in meat, poultry, catfish,
and certain egg products. In addition, it oversees the Pesticide Data Program (PDP). The PDP is published
annually and assesses a wide range of products, including fruits and vegetables, fish, grains, meat, dairy, and
infant formula.1 In the 2020 PDP report, over 99 percent of tested samples had residues below tolerances (MRLs)
established by the EPA, and 30 percent had no detectable pesticide residue.

Developing a Maximum Residue Level or Tolerance

When EPA sets a tolerance (or MRL), it must determine that the residue level is "safe," which is defined as "a
reasonable certainty that no harm will result from aggregate exposure to the pesticide residue." The setting of an
MRL is a relatively long process that includes defining the residue, conducting supervised crop field trials, and
performing consumer risk assessment and safety testing. The objective of the consumer risk assessment is to
determine whether the pesticide residue in a raw agricultural product poses an unacceptable risk to consumers as
a result of authorized application under local conditions of use (that is, as recommended on the pesticide label and
adhering to pre-harvest intervals).

To assess whether the expected residue level does not lead to unacceptable consumer risk, residue data are
combined with dietary information to estimate the potential residue intake by consumers, which is compared to
toxicological reference values. It is important to recall that an MRL is not a redline that signifies whether a health
effect is likely when it is exceeded. Rather, a residue detection above an MRL is a violation of the authorized limit
in the country where the crop was grown and the pesticide was registered.

The risk-based process to determine an MRL can be summarized as follows:

1. The residue is defined. Toxicological studies are conducted to determine the amount of exposure to the
active ingredient before having an adverse health effect. This amount is called the "no observable adverse
effect level," or NOAEL. The NOAEL is then multiplied by a safety margin, often set at 100.

2. Before an MRL can be granted for a commodity, the impact of residues from the use of the pesticide on
that particular crop is evaluated from the standpoint of consumer safety relative to dietary exposure.
MRLs can be granted only if the resulting total dietary exposures to consumers are below the regulatory
human reference values. These toxicological values include the acute reference dose (ARfD), which is the
estimated amount of a substance in food or drinking water that can be ingested in a 24-hour period (or
less) without appreciable health risk to the consumer, as well as the acceptable daily intake (ADI), which
is the estimated amount of a substance in food or drinking water that can be ingested over a lifetime
without appreciable health risks to the consumer.

3. The dietary intake of the pesticide is estimated by combining national or regional food consumption
statistics with the estimated residues in food and/or drinking water.

4. The registrant carries out a number of crop field trials to determine the magnitude of pesticide residues
in or on raw agricultural commodities at the time of harvest. MRLs reflect critical Good Agricultural
Practices (GAPs), wherein the pesticide is applied to the crop for the maximum number of allowed
applications, at the maximum allowed application rate and with the minimum pre-harvest interval
according to the directions on the product label.

5. Finally, the MRL is set based on statistical analysis of the range of pesticide residues found on the crop
from the field trials, after all applicable harvest and processing activities.

Beyond the steps above, registrants of conventional pesticides must provide detailed information prior to approval
of the product in the marketplace. This includes information on fate and transport of the active ingredient and
degradation byproducts, animal and plant metabolism studies, physical and chemical properties, and analytical
methods of detection. Some pesticide types, such as biopesticides, are exempt from many of these data
requirements.

“Under a food safety plan, pesticide residues should be

considered when evaluating the chemical hazards potentially
present in a food product, particularly if they are a known or
foreseeable risk.”

Pesticide Residues and Global Trade

As mentioned above, FDA monitors imported foods for pesticide residues and enforces the MRL. At times,
imported foods violate the U.S. tolerance limits due to exceeding allowable levels or detection of a residue where
no U.S. tolerance has been established. In an ideal scenario, all countries would determine a single set of MRLs for
crop type and active ingredient combinations. However, there are numerous reasons why this has proven to be
extremely difficult, resulting in different MRLs between countries. This reality leads to trade barriers and conflicts.
A key factor contributing to non-harmonized MRLs is that countries have different climates and agroecosystems.
Thus, they may have very different pests, pest pressures, crops, rainfall patterns, and agricultural practices, which
can result in the establishment of a pesticide application regimen with high variations between countries, and
consequently, different MRLs. What is common among MRLs, however, is that they all meet the safe toxicological
requirements for the population of the country.

To facilitate the establishment and harmonization of MRLs between countries, the Codex
Alimentarius Commission, an international standard setting body jointly overseen by FAO and the World Health
Organization (WHO), has established thousands of voluntary MRLs for global use. Codex MRLs are based on
rigorous, science-based risk assessment conducted by an international committee of assessors, called the Joint
Meeting on Pesticide Residues. Governments may choose to adopt these Codex MRLs or establish their own, using
scientific risk assessments. USDA's Foreign Agricultural Service plays a key role in technical consultation, capacity
building, and harmonization, particularly for developing countries.

Other Pesticide Residue Considerations in Food Safety

So, how do residues fit into a food safety plan or within corporate food safety culture? Under the Food Safety
Modernization Act (FSMA), many businesses must develop a food safety plan when selling human food or animal
feed. Within that plan, they conduct a hazard analysis to determine the potential for microbial, physical,
radiological, or chemical risks in their products. The hazard analysis process informs what preventive controls
may be needed to ensure safe food, and can bolster prerequisite programs, such as GAPs and Sanitary Standard
Operating Procedures (SSOPs).

Most acute pesticide poisonings from food consumption involve an adulterated or illegal application, malicious
act, or misuse of a pesticide container that was reused or mistaken for food or beverage. Even so, pesticide
residues should be considered when evaluating the chemical hazards potentially present in a food product,
particularly if they are a known or foreseeable risk. This may be more relevant for some ready-to-eat (RTE)
products without a downstream processing step or certain raw ingredients imported from countries with a history
of MRL violations. Supply chain control programs can be helpful in this process.

A secondary consideration is to assess what sanitizers or disinfectants are being used in a supply chain. This is
particularly relevant for any food contact surfaces, such as conveyor belts and tabletops. While these areas must
be properly cleaned and sanitized, it is critical to follow label instructions to ensure that efficacious levels of
residue are present to reduce microbial loads to acceptable levels, and also to limit residue uptake into finished
products. For products certified as organic, it is important that only allowed sanitizers are used on food contact
surfaces. Finally, food safety personnel should also assess the type and locations of pest control products, such as
fly strips and rodenticides, throughout the supply chain to prevent cross-contamination and potential residues in
products.

To summarize, pesticide residues are highly regulated through a multi-agency approach using a risk-based
framework. The lack of harmonization between countries in setting MRLs presents significant barriers to trade.
While residues are typically found below MRLs in most domestic and imported foods in the U.S., it is important to
assess their potential hazard to each specific scenario. Fortunately, many tools and databases exist to evaluate
residue levels, embedded within a robust scientific structure to deliver safe and high-quality foods.
References

1. U.S. Department of Agriculture, Agricultural Marketing Service. "Pesticide Data Program (PDP)." https://www.ams.usda.gov/datasets/pdp.

Dave Stone, Ph.D., is a Professor of Food Science and Technology at Oregon State University in Corvallis, Oregon.

Jason Sandahl, Ph.D., is the Founder of consulting business Ag Aligned Global.

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

> COVER STORY SCROLL DOWN

Video credit: Golden Sikorka/Creatas Video+ / Getty Images Plus via Getty Images

Supply Chain Management:

A Year in Review
To understand supply chain disruptions in a more systematic way,
broader scenario planning and more rigorous work processes are
needed
By John W. Spink, Ph.D., Michigan State University and Food Fraud Prevention Think Tank

We seem to be in the golden age of supply chain management. New appreciation has arisen for the fragility of our
networks and the complexity of keeping a company running. So, too, has arisen an unending stream of different
and more impactful supply chain disruptions. The past two years have been unprecedented, but to the point that
radical supply chain disruptions are now becoming precedented.

The disruptions are so extreme and so varied that it has become necessary to reset our expectations and the scope
of our management systems. We need a more systematic way to classify and understand supply chain disruptions.
New, broader scenario planning is needed. More rigorous work processes are also needed, so that we are not just
chasing from one fire to the next.

Supply Chain Management Background

My formal expansion into supply chain management, from focusing mainly on food fraud prevention, started in
September 2019 when I moved to the Michigan State University (MSU) Department of Supply Chain Management
within the University's Business College. I revamped the Introduction to Supply Chain Management undergraduate
course required for all business school students. My 15 years of developing and teaching applied business in
graduate courses at MSU, combined with my broad supply chain-related work experience at Chevron Corporation,
was an excellent fit for this task. I brought a holistic approach to the introductory concepts that used hot topics to
expand the student experience.

When we consider hot topics in supply chain management, we start with the impacts of COVID-19, then the
Ukraine–Russia conflict, and now inflation. Additionally, we were already tracking the trends of artificial
intelligence, data analytics, autonomous vehicles (in a warehouse and on the highway), electric cars, and the
massive increase of information flow from 5G networks. These events have led some experts to consider that we
are now experiencing more supply chain disruption and innovation than we have experienced in the last 50 years.

While the deeper and more formal dive into supply chain management concepts was new for me, from early on, it
was included in the "sciences of food fraud prevention."

"The crux of the last year of supply chain

management is that our problems have been
initially shifted from ‘known knowns’ to
‘unknowables.’"
The Challenge for Supply Chain Management

The disruptions are so extreme and so varied that it has become necessary to reset our expectations and the scope of
our management systems.

Just as food safety is a specific area of science, supply chain management is a scholarly discipline. Supply chain
management, which is focused on operations management, logistics, and distribution—or sourcing and
procurement—is a common undergraduate business degree. Beyond master's degree programs, over 100
universities offer Ph.D. programs in supply chain management. A number of academic journals publish only on
these topics. That said, a lack of awareness of the rigorous processes and procedures often characterizes this
discipline. Supply chain management is often considered to be valuable only for manufacturing plant
management, procurement, or transportation personnel. A vast and complex operations and communication
network can be more efficiently engaged by a business' food safety business function.

To step back to the basics, supply chain management oversees the movement of everything from everywhere to
everywhere else. At any time, anything can go wrong that will shut down an entire company. This the starting
point—the challenge and everyday intensity of supply chain management.

Take a moment to consider some recent supply chain disruptions:

The Suez Canal became blocked by a large vessel in 2021, causing a backlog of ships waiting to get through
for a seemingly indeterminate amount of time (in total, it was 106 days)

A Texas ice storm in February 2021 disrupted travel across the U.S. much longer than during a typical
freeze/thaw cycle

A computer chips shortage for vehicles has been seen since the start of COVID-19 supply chain disruptions

COVID-19 is changing almost everything, from a massive shift in consumer shopping to an almost instant
shift to curbside pickup and delivery, as well as radical shifts in the type of products that are in demand (think
Peloton bikes and baking yeast)

COVID-19 impacts the logistics and transportation networks from ports and facilities shutting down, as well
as production and manufacturing stopping, then starting, and then stopping again

Companies are having to quickly add supply and suppliers to keep running while balancing the risks of
unknowns

Companies are still having trouble keeping up with manufacturing, getting enough raw materials, and
efficiently transporting their products to customers.

What has fundamentally changed is that our old way of responding is no longer possible. Basically, all the usual
buffers were—or are still—gone, such as having safety stock, using backup suppliers, being able to expedite a few
shipments to get caught up, being able to scale up from optimal utilization to maximum, or the option to increase
lead times on deliveries. Think about these assumptions that are shattered:

No automatic assurance of supply: In the past, if a product shortage arose, a company would usually just
contact another supplier. Assurance of supply was available, even if it cost more to buy and transport the
alternative product.

No automatic alternate shipping routes: If a problem with one shipping route arose, other ways to get the
product existed. If a port shutdown occurred, then the product could be moved through another port or more
costly rail or truck transportation could be hired. At worst, if land and sea borders were blocked, air cargo
transportation could be utilized. Once the COVID-19 pandemic hit, air cargo was booked solid and could not
be obtained at any cost.

No more "operating out of inventory": Everyone whittled down their inventory at the start of the pandemic.
Everyone then tried to restock three months of safety stock instantly. The excess manufacturing capacity to
ramp up did not exist. It became impossible for companies to operate solely on their own inventories, their
suppliers' inventories, or to ask their customers to shorten their days-of-supply inventory.

No more "just expediting shipments": This restraint has two challenges. The first challenge is never being
able to catch up. It is impossible to get caught up when a company is two weeks behind, expediting orders,
and only producing for the customer orders. The company will be stuck in paying or expedited shipping for
everything. The second challenge is the transportation shortage, caused by a combination of unprecedented
demand in the truck and rail industry and a commercial driver shortage.

Consumer delivery has shifted from days to hours: It is amazing how frequently consumers order products
online that are delivered later that day. Suppliers are placing more products closer to consumers to meet the
increased competition in the marketplace. This also creates a massive spike in the amount of inventory that is
held in the warehouses. These factors are fundamentally changing warehousing and logistics.

No equilibrium, no patterns, no "normal": On top of these assumptions, the consumer demand, operations,
and logistics have not been able to reach equilibrium. The supply and demand have continued to fluctuate, so
the supply chain cannot catch up. Before the pandemic, disruptions and shutdowns due to a lack of personal
protective equipment (PPE) did not usually occur, but COVID-19 created that problem. Then the Ukraine–
Russia conflict added another unprecedented supply chain disruption. All together, these many "events" and
"effects" have led to a new and different type of inflation pressure. There is no equilibrium.

The multiplication of all the assumptions: With some system equilibrium, the system could catch up even
in the face of one of these factors. If one of these factors could be solved, then it would pressure the other
factors.

The crux of the last year of supply chain management is that our problems have been initially shifted from "known
knowns" (i.e., "simple" problems such as a delayed truck delivery) to "unknowables" (i.e., "chaotic," unforeseen
problems such as at the start of the COVID-19 pandemic and the Ukraine–Russia conflict). Over time, we might
expect some consistency and shift to "unknown unknowns" (i.e., "complex" problems where we expect delays of
some kind) or, with more information, a shift to "known unknowns" (i.e., "complicated" problems such as when we
know suppliers may have trouble delivering on time, but we do not know what product). For further clarification,
see the sidebar below.

Known Knowns? Unknown Unknowns?

Know Your Problem Type to Frame Your Response
If you do not understand the type of question you are answering, you may use the wrong tool. For example, detecting species swapping is very
different than preventing country-of-origin labeling fraud. Known known? Known unknown? Unknown unknown? The classification makes a
difference. So often, we—as humans, consumers, food scientists, criminal investigators, etc.—apply the same tool when responding to every
problem.1

The "type of problem" classification system is helpful at the beginning of a food fraud investigation because it can provide the foundation for a
more standardized response. When you realize the type of problem, then you can understand how the most efficient first step could be choosing
an immediate cause-and-effect response (e.g., peanut allergen adulterant substance in cumin requires an immediate test for peanut allergen).
In other cases, it may be best to start with a more complex active scenario development (e.g., trying to understand the evolving fraud
opportunity seven days after Russia entered Ukraine).

Types of problems include:

Simple (known known—e.g., water on the floor): For example, the risk of someone falling if there is water on the floor. These
were the traditional supply chain management problems such as a supplier being unavailable or a truck getting delayed.

Complicated (known unknowns—e.g., hurricane season): For example, the risk of supply chain disruptions from hurricanes over
a year. It is known that hurricanes hit the U.S. Gulf Coast over a certain span of months, but precisely when they will arrive or their
intensity are not known.

Complex (unknown unknowns—e.g., most food fraud events): For example, most new food fraud events seem to fall into the
complex/unknown unknowns category. (If the same type of food fraud keeps occurring, however, then the problem may become
either a "simple" or "complicated" problem.)

Chaotic (unknowables—e.g., Ukraine–Russia): The September 11 terrorist attack falls into this category, especially while that
event was occurring. The Ukraine–Russia event probably falls into this category regarding food fraud and the food supply chain.1

Looking at these events from the last few years, what has become apparent is that the supply chain disruptions
stemming from them are here to stay for a while. Also, there is a growing awareness that it is not wise to wait for
things to "go back to normal," or to even try to predict the "new" normal.

The Foundation of Supply Chain Risk Management

We need a more methodical way to classify and understand to supply chain disruptions.

While supply chain management seems to be common sense, it is important to review the foundation and
fundamentals before creating new methods or processes. Fortunately, the field of supply chain management has a
long and rigorous body of work to draw upon. Specifically, the discipline focuses on supply chain risk, risk
management, and classifying supply chain disruptions.

From the supply chain management literature come several important definitions:

Supply chain risk: The likelihood and impact of unexpected macro- and/or micro-level events or conditions
that adversely influence any part of a supply chain leading to operational, tactical, or strategic level failures or
irregularities.2

Supply chain disruption: Unplanned and unanticipated (event) that disrupts the normal flow of goods and
materials within a supply chain.3

Supply chain risk management (SCRM): The process of identifying, assessing, and mitigating the risks to
the integrity, trustworthiness, and authenticity of products and services within the supply chain.4

Supply chain disruptions: Unplanned and unanticipated events that disrupt the normal flow of goods and
materials within a supply chain and, as a consequence, expose firms within the supply chain to operational
and financial risks.5,6,7,8

Supply chain disruptions may be viewed as events, risks, or vulnerabilities. The disruption can be classified by
events, causes, effects, and underlying factors. The application of vulnerability is aligned with the food fraud
prevention application.

This SCRM and supply chain disruption classification system is implemented in a formal and integrated plan that
supports formal business activities such as advanced planning and scheduling (APS), sales and operations
planning (S&OP), manufacturing scheduling, logistics scheduling, and into the corporate finance and accounting
systems. The takeaway point for food safety management and food fraud prevention is that implemented systems
already exist that can contribute to efficient control of risks and vulnerabilities.

The first step in addressing and preventing supply chain disruptions is understanding what kind of problem is
being addressed. Not all supply chain disruptions are the same. When I started researching supply chain
disruptions, I did not find a formal list or classification system. Also, pandemics were not a type of event. It was a
challenge to figure out where a pandemic should be categorized. A pandemic is a root cause of other types of
events. The "natural/hazard" category of a fire assumes a fire at your facility or a supplier's facility, not a forest fire
in the region.

TABLE 1. Types of Supply Chain Disruptions

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For food safety management and food fraud prevention, we now have a way to explain our problems in supply
chain management terms. This supply chain disruption classification system helps define the full impact of the
problem and the root causes. By using this classification, we can more efficiently utilize the supply chain risk
management system.

Broader Scenario Planning

New, broader scenario planning is needed.

There is an efficiency in narrowing our focus to the most common and worst problems. We can refine our focus
when we have stable problems and a lot of data. The current problem is that we are experiencing new problems,
and we have very little, if any, useful historical data. Now what? What is normal? What is the "new" normal? How
long will the new normal last?

Fortunately, we have a way to address this uncertainty. We have the perspective that food safety problems have
evolved from "simple" or "complicated" to "complex" or "chaotic." When the future is uncertain, picking one way to
respond might be simple, but it is more effective to utilize scenario planning.

Scenario Planning

The supply chain disruption is total and completely uncertain, so the traditional resources and responses to food
fraud prevention may be outdated. The entire landscape must be reviewed. Usually, we need to assess only simple
scenarios such as how a shipment of product could impact our business (the result is a simple scenario and one
action, so we do not even think about this as scenario planning). While a corporate strategy and board of
directors-level risk committee would consider geopolitical scenarios, it has rarely been included at our front-line
level. The result of scenario planning is to consider all the variables and then the full range of all possible future
developments. Most probable scenarios will emerge. Also, based on the type of problem (simple, complicated,
complex, or chaotic), a widening range of what could occur will be seen (Figure 1).

FIGURE 1. Hierarchy of Scenarios for Supply Chain Disruptions

Vulnerability Assessment Update

After identifying the scenarios that could occur—including the most probable and the range of higher potential—
the vulnerability assessment can be updated. At this point, new incidents probably have not occurred and are not
yet supply chain disruptions; however, some system weaknesses may exist that could cause them to appear. Also,
there may be some pretty simple and low-cost countermeasures or control plans that can be put in place to reduce
vulnerability.

Enterprise Risk Management Update

These scenarios and updated vulnerability assessment results should be fed into the Enterprise Risk Management
(ERM/COSO) systems. This updated information will help inform the corporation of the shifting enterprise-wide
risks. Also, this will calibrate which vulnerabilities have shifted above the risk tolerance.

Implement in a Real Management System

As defined by the International Organization for Standardization (ISO) and others, a formal management system
is a set of policies and procedures that comprise the way in which an organization manages the interrelated parts
of its business to achieve its objectives. For addressing food safety management, food fraud prevention, or supply
chain disruptions, this is as simple as assigning team members, conducting regular meetings that are documented,
conducting regular activities such as scenario development or updating vulnerability assessments, and then
reporting the compliance progress to company management. More complex businesses operations may require
more extensive documentation and controls to fulfill legal obligations and meet organizational objectives.

As an application, consider the Ukraine–Russia conflict. For example, Ukraine is a significant producer of
sunflower seeds and oil. On the day that Russia entered Ukraine, the scenario planning would predict supply and
demand problems for sunflower and related products, as it is known that stressed supply creates a food fraud
vulnerability. The food fraud acts that occur during supply shortages are substitution, dilution, or short-weighting.
Simple first steps could be to ensure that authenticity tests are being conducted, that the concentration is being
monitored, and that the weights or volumes are being confirmed. Those steps probably reinforce existing work
processes and would vastly reduce the food fraud vulnerability.

Takeaway Points

More rigorous work processes are also needed, so that we are not just chasing from one fire to the next.

New activities should be coordinated under a real management system. Often, the activities are a series of one-off,
ad hoc responses to a problem or a project. If there were no real food fraud prevention management system in
place, then there would have been no proactive review of the impact of the Ukraine–Russia conflict. It may have
been surprising when sunflower product pricing spiked or when availability became constrained. It will definitely
be surprising if the food fraud vulnerabilities become supply chain disruption events. If a real food fraud
prevention management system had been in place, then these problems could have been prevented or at least
mitigated.

Takeaway points include:

Supply chain management concepts can be applied to food safety management

 Current food safety and food fraud risk assessment methods can be adapted to fit into supply chain
management and corporate risk assessments

For an efficient discussion of risks—specifically, a new risk explained in relation to all other enterprise-wide
risks—the assessment should be calibrated with the overall, company-wide financial risks.

Action items include:

Identify the team or accountable person (Is that you? Your supervisor?)

Review your current documentation, methodologies, and procedures

Review your audits and food safety management system (FSMS) standard to understand the scope and
application of hazard identification

Conduct a gap analysis of your food safety management and food fraud prevention to identify where early
warning and proactive responses to disruptions could be improved

Re-educate yourself and others before you start creating or implementing plans (see sidebar)

And then, propose, get approval, and implement a management system.

Free Food Vulnerability Assessment Training Resources

To aid in re-educating yourself and others before you start creating or implementing plans, please take advantage of the free food vulnerability
assessment training resources listed below:

The Food Fraud Prevention Think Tank is offering a new, on-demand, Massive Open Online Course (MOOC) on Food Fraud Supply
Chain Disruptions

USDA Agricultural Marketing Service's Organic Integrity Learning Center offers online training that supports the professional
development and continuing education of organic certifiers, inspectors, reviewers, and other professionals working to protect organic
integrity

Senior Stewards Acting for the Environment (SSAFE) seeks to unite the more than 4,000 residents at Kendal affiliates, residing in
ten U.S. states, in addressing climate change at the global, national, and local levels to ensure a more sustainable planet

The Food Authenticity Network (FAN) offers a variety of tools, publications, and training resources related to food fraud, food
authenticity, and food safety

Together, these takeaway points and action items will help you and your organization create processes and
procedures through a management system. The management system is a way to help organize your business to
increase the efficiency of all activities, which starts with reducing disruptions. Food safety and food fraud are root
causes of disruptions and so are key to your company-wide management system and supply chain management.

References

1. Spink, John W. "Known Knowns? Unknown Unknowns? Know Your Problem Type to Frame Your Response." July 19, 2022.
https://blog.foodfraudpreventionthinktank.com/known-knowns-unknown-unknowns-know-your-problem-type-to-frame-your-response/.

2. Spink, John W. Supply Chain Management Introduction: Sourcing, Operations and Logistics. Jacksonville, Florida: York Partners LLC. To Be Published
(2022). www.scmintro.com.

3. Spink, John W. "Food Safety as a Supply Chain Management Problem." Presented at Food Safety Summit, Rosemont, Illinois. May 12, 2022.

4. Craighead, Christopher W., Jennifer Blackhurst, M. Johnny Rungtusanatham, and Robert B. Handfield. "The Severity of Supply Chain Disruptions:
Design Characteristics and Mitigation Capabilities." Decision Sciences 38, 1 (2007): https://doi.org/10.1111/j.1540-5915.2007.00151.x.

5. Svensson, Göran. "A conceptual framework for the analysis of vulnerability in supply chains." International Journal of Physical Distribution and
Logistics Management 30, 9 (2000): https://www.emerald.com/insight/content/doi/10.1108/09600030010351444/full/html.

6. Hendricks, Kevin B. and Vinod R. Singhal. "The effect of supply chain glitches on shareholder wealth." Journal of Operations Management 21, 5
(2003): https://doi.org/10.1016/j.jom.2003.02.003.

7. Kleindorfer, Paul R. and Germaine H. Saad. "Managing Disruption Risks in Supply Chains." Production and Operations Management 14, 1 (2005):
https://doi.org/10.1111/j.1937-5956.2005.tb00009.x.

8. Stauffer, David. "Supply Chain Risk: Deal With It." Working Knowledge. April 28, 2003. https://hbswk.hbs.edu/item/supply-chain-risk-deal-with-
it.

John W. Spink, Ph.D., is an Assistant Professor in the Department of Supply Chain Management in the Eli Broad College of Business at Michigan State
University. He is also the Director of the Food Fraud Prevention Think Tank.

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Dairy HACCP Through the Years 

The dairy industry has seen many regulatory changes, including the incorporation of
the FSMA Preventive Controls Rule within the Pasteurized Milk Ordinance
By Jason Crafts, Director of Quality Assurance, Gossner Foods Inc.

Shortly after I started working as a Quality Assurance Manager two decades ago, one of the supervisors in
production told me that Hazard Analysis and Critical Control Point (HACCP) programs would not be around in the
years ahead, as they would eventually become obsolete. Some 20-plus years later, HACCP is still alive and well.
Many of the techniques used in creating a HACCP plan are shared with other types of plans, such as food quality
and food defense plans. Determining what is critical to monitor, monitoring those parameters in real time,
responding when a deviation occurs, and documenting each step along the way are the hallmarks of a successful
HACCP plan.

Early in my career as Quality Assurance Manager at Gossner Foods Inc., I took a HACCP workshop presented by
Northwest Food Processors Association, McDonald's Corporation, Campbell Soup Company, and National Food
Lab Inc. My main takeaway from the workshop was that there was an abundance of opinions about HACCP (this
was in 1994), particularly regarding how to implement and maintain the system. Gossner Foods already had a
HACCP System in place, although it was elaborate and cumbersome to understand and implement. There were no
regulatory requirements for dairy HACCP at the time, but many of our customers required that we have a system
in place.

The PMO and NCIMS HACCP Dairy Pilot Program

Before continuing, it may be helpful to provide some background on the regulatory system that Gossner Foods
falls under. Gossner Foods is considered a Grade "A" dairy plant that must be in compliance with the regulations
spelled out in the Grade "A" Pasteurized Milk Ordinance (PMO), a regulatory guidance document published by the
U.S. Food and Drug Administration (FDA). The PMO covers sanitary standards from cow to carton. State
Regulatory Agencies adopt the PMO (or equivalent regulation) and oversee the inspection and licensing of plants
within their states, while FDA Milk Specialists oversee the state agencies to ensure that they are doing their job.
The PMO is updated every two years based on proposals submitted to the National Conference on Interstate Milk
Shippers (NCIMS), a cooperative program with representatives from state regulatory agencies, the dairy industry,
and academia, with FDA serving as advisor. Proposals are reviewed, accepted, rejected, and/or edited, first by an
assigned committee and then by assigned councils. The proposals are eventually voted on by representative
delegates of all state regulatory agencies. If accepted and concurred by FDA, the proposal is incorporated into the
PMO and/or other appropriate related regulatory documents.

In the summer of 1999, our FDA Milk Specialist asked the Gossner Foods management to consider becoming part
of the NCIMS HACCP Dairy Pilot Program, which was being developed as a result of an NCIMS proposal. New
regulatory programs proposed to the NCIMS may be studied under a pilot program before final consideration.
Some questions were raised regarding Gossner Foods' participation in the pilot because the company is an aseptic
shelf-stable milk facility and not a traditional Grade "A" plant with pasteurization. The PMO, at that time,
regulated aseptic shelf-stable milk in addition to the FDA Low Acid Canned Food group. In the end, the Gossner
Foods facility in Utah was selected as one of the pilot plants for the six regulatory regions delineated by FDA. In
addition to the dairy plants that agreed to participate, the state regulatory agency where the plants were located
(in this case, Utah) also needed to commit.

At the start of the pilot program, both the industry and regulatory personnel involved received multi-day training
developed and presented by the NCIMS HACCP Implementation Committee (HIC). The HIC consisted of federal
and state regulatory personnel, as well as representatives from industry and academia. Some of the volatility of
the ideas associated with HACCP and what I had experienced in earlier trainings had settled, and protocols were
becoming more standardized. I felt encouraged and enthusiastic to implement what I had learned from the HIC
training.

As Gossner Foods entered the pilot program, our state regulatory representative and the Regional FDA Milk
Specialist conducted a review of the HACCP programs that my company had developed thus far. Some differences
of opinion were expected, but I remember questioning if we had gone through the same training as regulatory,
because the regulators seemed to interpret so differently the things that my colleagues and I thought we
understood so well. Working with FDA and our state regulatory agency led to a flurry of escalated learning from
preconceived ideas, as well as gaining insight on the PMO from regulatory officials. All parties learned and worked
on developing HACCP concepts as they applied to our Utah facility and the NCIMS program. As a result, Gossner
Foods became a facility recognized by regulatory as operating under the Voluntary HACCP Dairy Pilot Program in
February 2000. Through our combined efforts to better conform to the principles of HACCP, I gained a better
understanding of processing and packaging systems and their associated risks.

In these early years of the Dairy HACCP Pilot Program, there were multiple calls with industry and the
International Dairy Foods Association (IDFA) as we learned and worked together to refine and implement the
regulation. From the efforts of the HIC and the successful Pilot Program, the regulatory requirements were
determined for dairy facilities that wished to participate as an "audited" HACCP plant as an optional alternative to
being regulated under the traditional PMO "inspection-based" program. A new appendix, Appendix K, HACCP
Program, was added to the PMO in 2003 that contained these regulatory requirements. This optional alternative
outlined in Appendix K was considered equivalent to the traditional regulatory requirements also outlined in the
PMO. Once Appendix K was finalized and included in the PMO, the pilot program ended and Gossner Foods
continued in the optional Dairy HACCP Program. Our plant, from top management down, was invested; our state
regulatory agency was invested; and we both saw the benefits.

Over time, I began to participate in the HIC and became familiar with all of the committee members. In May 2009 I
was asked by the current Chair of the HIC if I would be willing to be Chair because that individual was changing
jobs. I agreed, knowing that I could count on the wonderful HIC committee members for help.

“FDA, state regulatory agencies, and industry representatives

eventually came to a consensus that a new appendix was
needed to align the PMO with the Preventive Controls Rule, with
Appendix K shadowing those changes.”

FSMA and the PMO

Just over five years later, in 2014, the Grade "A" dairy regulatory agencies (both FDA and state) were deliberating
over the best way to incorporate the Food Safety Modernization Act (FSMA) Preventive Controls (PC) Rule within
the PMO. Consideration was given to requiring all Grade "A" dairy facilities to implement and comply with the
requirements in Appendix K, HACCP Program, as the proposed Preventive Controls Rule aligned well with that of
HACCP, with some minor differences. For example, the PC Rule requires other preventive controls that are not
necessarily Critical Control Points, but may be addressed under prerequisite programs under HACCP (e.g.,
sanitation preventive controls). Additional requirements of the PC Rule, such as a required supply chain program
and environmental monitoring verification, also would need to be addressed.

As deliberations continued, the sentiment gradually transformed into the thought process that the PMO was and
is the food safety plan for Grade "A" dairies and that, with some additions, the PMO would comply with the FSMA
PC Rule. The NCIMS Liaison Committee, made up of state regulatory and industry representatives, was tasked by
the NCIMS Executive Board to incorporate preventive controls into the PMO. Whereas operating under Appendix
K was intended to continue to be an equivalent and optional alternative to traditional compliance to the PMO, the
HIC was to stay abreast of the activities of the Liaison Committee. I participated in many conference calls with the
Liaison Committee regarding the changes. From those meetings, we were able to incorporate some changes to
Appendix K in the PMO and prepare proposals for changes to be submitted and voted on at the 2015 NCIMS
Conference. Several proposals submitted by the Liaison Committee and one proposal submitted by the HIC were
passed. These changes were incorporated into the 2015 PMO, but while they were designed to align the PMO with
the PC Rule, FDA and others felt that they fell short. FDA, state regulatory agencies, and industry representatives
eventually came to a consensus that a new appendix was needed to align the PMO with the PC Rule, with Appendix
K shadowing those changes.

With the direction clear, the details needed to be developed and incorporated into the PMO and Appendix K. Under
the leadership of the Liaison Committee in cooperation with FDA, a proposal was submitted to the 2017 NCIMS
for inclusion of a new appendix in the PMO: Appendix T, Preventive Controls for Human Food Requirements for
Grade "A" Milk and Milk Products. Further deliberation occurred at the NCIMS Conference's committee and council
meetings. The HIC, with years of PMO food safety program experience, was directly involved in the process, with
the added intent of ensuring parallel equivalency of Appendix K with the new Appendix T and alignment with the
PC Rule. Proposals for both the new Appendix T and amendments to Appendix K were approved at the NCIMS
Conference, adopted by FDA, and incorporated into the 2019 PMO. Accolades were formally announced to the
Liaison Committee and the HACCP Implementation Committee at the end of the Conference by the Chair of the
NCIMS Executive Board. The two committees were thanked for their "Herculean efforts to align these two historic
programs into a single, actionable food safety program for Grade 'A' milk and milk products."

Over the years, I have been a witness to the many advantages of the food safety system outlined in the PMO's
Appendix K. Having a HACCP program that is regularly reviewed in detail by the state and FDA seems to carry
weight with our customers. Also, having an independent, multi-disciplined, diverse committee in the HIC, which
focuses on staying ahead of the curve for HACCP, provides dividends for my company.

HIC Training Subcommittee Chair Steve Murphy assembled a comparison document between Appendix T and
Appendix K in the PMO. It is a multipage document, but I have recreated a portion of it here regarding the Food
Safety Plan under Appendix T and under Appendix K of the PMO, to help visualize the food safety plan
requirements at a glance (Figure 1).

FIGURE 1. Industry Food Safety / Plan Program Requirements

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Jason Crafts is Director of Quality Assurance at Gossner Foods Inc.

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 > SPOTLIGHT

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A Critical Look at Reducing the Risk of

Salmonella from Poultry, Part 2: On-Farm Control
Reducing Salmonella in poultry requires controlling the introduction of the
microorganism into the poultry flock
By Harshavardhan Thippareddi, Ph.D., John Bekkers Professor of Poultry Science, Department of Poultry Science, University of Georgia; Manpreet
Singh, Ph.D., Professor and Head, Department of Food Science and Technology, University of Georgia; Todd Applegate, Ph.D., R. Harold and Patsy
Harrison Chair in Poultry Science, Department of Poultry Science, University of Georgia; and Sudhir Yadav, Ph.D., Department of Poultry Science,
University of Georgia

Sources of Salmonella colonization in chickens have been extensively discussed in Part 1 of this article.1 Part 2
will emphasize on-farm (or pre-harvest) controls for minimizing the prevalence and/or concentrations of
Salmonella in broilers. A number of sources exist for Salmonella colonization of the broilers:

1. Poultry house external environment

 2. Poultry feed

3. Hatchery

4. Chicks

5. Poultry house internal environment

6. Water

7. Bird droppings and litter.

An effective and significant risk reduction strategy is to minimize the potential for colonization from each of these
sources. This article discusses practical Salmonella control measures that can be implemented by the poultry
industry at the pre-harvest stage or on the farm.

Controlling Salmonella Introduction into the Flock

Reducing Salmonella prevalence in poultry meat and broiler carcasses requires reducing and controlling the
introduction of the microorganism into the poultry flock. Once Salmonella introduction and subsequent
colonization occurs even in one bird in a flock, the rapid spread of the microorganism to other birds through
horizontal transmission can occur within a short period of time. Salmonella colonization results in the excretion of
the Salmonella cells in the feces within a few days in high concentrations, often up to 9 log CFU/g. Even if the
fecal droppings dry over time, the ability of Salmonella to survive low-moisture conditions for extended periods of
time and the coprophagic tendencies of the birds can serve to spread and further colonize other birds in the flock.
There is a critical need to reduce and/or minimize the risk of Salmonella introduction into the flock from the
identified sources of this microorganism. However, eliminating the risk of Salmonella introduction from the
identified sources of the microorganism on the scale of the entire poultry industry may not be economically
feasible. As such, there is a need to identify other measures that can modulate the spread and colonization of the
microorganism.

Poultry house surroundings have been identified as a source for Salmonella and, potentially, other foodborne
pathogens such as Campylobacter. Spread of avian influenza in farm birds through wild birds is an excellent
example of the role the external environment can play. Other factors—such as control of on-farm personnel and
their hygiene in moving between poultry houses; visitors, especially those that have been in contact with other
birds on other farms; and upkeep of poultry house surroundings—are important for control of Salmonella spread
and colonization to chickens. Proper biosecurity training onsite, as well as the implementation and maintenance
of biosecurity measures, are important to minimize the spread of Salmonella across flocks.

Biosecurity refers to practices designed to prevent the introduction and spread of disease-causing microorganisms
on farms. While these measures are meant to mitigate the spread of microorganisms that cause poultry diseases,
they are also effective in minimizing the spread of Salmonella and Campylobacter. This can be accomplished by
maintaining the farm, equipment used to manage the operations within and outside the poultry house, boots,
gowns, birds within the house, and vehicles that frequent the farm in a manner that minimizes the spread of
microorganisms such as bacteria and viruses. Care should also be taken to minimize the presence and spread of
rodents and pests across areas within the farm.

Biosecurity is a critical aspect of minimizing the risk of Salmonella introduction and colonization of birds in
poultry houses. Primary biosecurity measures for poultry farms are described thoroughly in a University of Georgia
Extension Bulletin.2 These measures include the following actions:

Keep visitors to the farms to a minimum

Maintain proper hygiene of personnel entering each house

Keep all animals out of poultry houses

Practice sound rodent and pest control programs

Avoid contact with non-commercial poultry or wild birds

Inspect flocks daily

Keep areas around the poultry houses and feed bins clean.

Implementation of all of these measures is critical for minimizing the risk of Salmonella introduction into the
flock.

In addition to the above measures to reduce and/or eliminate the sources of Salmonella, additional mitigation
strategies that can be implemented are broadly categorized as: (1) poultry house management, (2) dietary
strategies, and (3) immunity modulating strategies.

"Recent changes in consumer awareness and regulatory pressure

on the potential risk of development of antibiotic-resistant
human pathogens have resulted in industry adopting an
antibiotic-free production system."
Poultry House Management

Eliminating sources of Salmonella in the exterior environment of the poultry house, as currently structured or
constructed in the U.S., may be impossible. However, reasonable measures to minimize the risk of introduction of
the microorganism to the interior of the poultry house, and eventually the birds, should be implemented. These
measures include proper hygiene of personnel entering the poultry house—e.g., cleaning and sanitizing of the
boots and providing boot dips prior to entering the poultry house, as well as sanitation of any equipment
introduced into the poultry house.

In addition to these measures, proper litter management is critical as the birds are continually exposed to litter
throughout the growth period, and the litter can be a source of Salmonella from previous flocks. The rising costs of
poultry bedding material and/or the difficulty of procuring bedding material has resulted in U.S. poultry producers
reusing the same litter for multiple flocks, with a top dressing of fresh litter between flocks. This practice allows
Salmonella persistence in the litter if it is not properly managed or treated. While the practice has the benefit of
contributing beneficial bacteria to the subsequent flocks, Salmonella can survive in the litter if present in the prior
flock, thus resulting in horizontal transmission to subsequent flocks.

In a recent study, approximately 46 percent of the litter from poultry farms was positive for Salmonella, with
populations between less than 1 log CFU/g and greater than 5 log CFU/g.3 While the down time between the flocks
can vary, it should not be less than 14 days to allow for pathogen (necrotic enteritis causing Clostridium
perfringens and coccidia pathogen Eimeria spp.) destruction and infection to the new flock. Proper windrowing of
the litter between flocks can be a means to reduce these poultry pathogens, as well as populations of Salmonella, if
not eliminate it from the poultry litter. Reduction in Salmonella population can occur in the litter based on the pH,
water activity, and temperature. Reduction in Salmonella population in litter may not be adequate, however, as
even low numbers can result in colonization of the birds and subsequent spread through fecal droppings.

Research is underway to identify temperature and humidity conditions that would significantly reduce the
populations of C. perfringens, Eimeria spp., and Salmonella. Elimination of Salmonella in poultry litter should be
the goal of windrow composting practices adopted by poultry farmers. However, effective composting is reliant
upon achieving adequate temperatures. Thus, windrow composting must be done as close to flock removal as
possible to allow for adequate time to be effective.

Dietary Strategies

Supplementing poultry feed with antibiotics has been practiced for the past five decades, and use of antibiotics at
subtherapeutic levels has been a primary practice of the industry to minimize the risk of pathogenic and non-
pathogenic enteric microorganisms. Antibiotic usage, although at sub-therapeutic levels, has resulted in
improvement to animal gut health and, consequently, reduction in the risk of certain pathogens.

However, recent changes in consumer awareness and regulatory pressure on the potential risk of development of
antibiotic-resistant human pathogens have resulted in industry adopting an antibiotic-free (ABF) production
system. At present, approximately 46 percent of all poultry meat produced in the U.S. is produced under the ABF
system, which has resulted in poultry integrators searching for alternatives to antibiotics to provide the same
protection to bird gut health and associated issues. Several strategies have been evaluated, including feeding the
birds organic acids, probiotics and prebiotics, botanicals, bacteriocins, bacteriophages, novel compounds, and
other feed additive combinations to provide the same level of protection in terms of gut health. Each of these
strategies is discussed below.

Organic Acids. Supplementation of poultry feed or drinking water with organic acids has gained prominence with
the switch to the ABF production system. The organic acids evaluated include short-chain fatty acids (e.g., formic,
acetic, propionic, and butyric acids) and medium-chain fatty acids (e.g., capric, caproic, caprylic, and lauric acids)
to acidify the feed, as well as the bird's gut environment, and to reduce the risk of high Salmonella populations in
the chicken gut contents, which may contaminate the carcasses during processing. While the main mechanism of
action of these organic acids is through acidification of the chicken gut contents, research has indicated minimal
drop in chicken gut pH, while providing the protective bacteriostatic activity through controlling Salmonella
populations.

Combinations of organic acids show more promise, with buffered formic acid and sodium formate providing
reductions in Salmonella prevalence in birds with increasing doses (up to 0.9 percent4). In some cases, the organic
acids were administered through drinking water closer to the harvest age of the birds. While research has shown
that organic acid supplementation can reduce the risk of Salmonella prevalence and/or concentrations in the
chicken gut system, the results are not consistent across studies. Other strategies for reducing Salmonella
contamination in the feed and/or feedstuffs includes the use of formaldehyde or other aldehyde-based products.

"In ovo vaccination may be valuable in controlling Salmonella in

poultry as it presents the easier delivery of vaccine to the chicks,
with the ability to immunize greater than 70,000 eggs within a
short period. "
Probiotics and Prebiotics. The concept of probiotics in human health has been the focus of research for decades,
and several probiotics are commercially available. The human health benefits from such probiotics have been
numerous, with the primary benefits being the maintenance of gut health and the balance of bacteria within the
various segments of the gastrointestinal tract (GIT).

Probiotics are either single or mixed cultures of live microorganisms that provide beneficial effects in maintaining
host intestinal microbial balance.5 Research on the use of probiotics in poultry is extensive, with the most
common being lactic acid bacteria including several species within the genera Lactobacillus, Lactococcus, and
Bifidobacterium, and others including Bacillus, Enterococcus, Escherichia coli, some molds, and yeasts. The most
common mode of action attributed to probiotics is the competitive exclusion (CE), where the beneficial
microorganisms occupy the common niche in the chicken gut, hence excluding the attachment and subsequent
colonization with foodborne pathogens such as Salmonella.

Prebiotics are non-digestible feed ingredients that pass the upper GIT and enhance the activity of the beneficial
microorganisms (probiotics) in the colon. The prebiotics characteristically are not absorbed in the upper GIT, are
resistant to the acidic pH, stimulate the growth and metabolic activity of beneficial microorganisms, and modulate
the host defense system. The common probiotics used in poultry include fructo-oligosaccharides (FOS), inulin,
mannan-oligosaccharides (MOS), and xylo-oligosaccharides (XOS). Several of these are components of yeast cells
—the cell walls and fermentation products.

The prebiotics and probiotics seem to work in tandem, providing the beneficial effects of maintaining gut health,
with beneficial effects in reducing Salmonella colonization and shedding; reducing C. perfringens, E. coli, and
Eimeria populations; and reduced mortality.

Botanicals. Synonymously referred to as phytogenic feed additives, phytonutrients, phytobiotics, phytochemicals,

or plant-based feed additives, botanicals are a wide range of compounds derived from plants with a variety of
biological activities. These can be classified as (1) phenolic compounds (apigenin, quercetin, curcumin, and
resveratrol), (2) organosulfur compounds (allicin and other compounds), (3) terpenes (eugenol, thymol, carvacrol,
and artemisinin), and (4) aldehydes (cinnamaldehyde and vanillin).7 Research indicates that the essential oils
derived from botanicals such as thyme, basil, and oregano are effective in controlling foodborne pathogen
colonization and shedding. The majority of these oils are considered as Generally Recognized as Safe (GRAS) and,
therefore, suitable for supplementation of poultry feed. These agents modulate gut health and often improve
microbial community; consequently, they reduce colonization of foodborne pathogens. The efficacy of these oils
depends on several factors such as the inclusion level and feed composition.

Bacteriocins. These are peptides produced by certain bacteria and possess either wide- or narrow-spectrum
antimicrobial properties. Often, bacteriocins are produced by lactic acid bacteria (LAB) such as Lactobacillus,
Lactococcus, Pediococcus, and other bacterial genera. Often, some of the antimicrobial properties of the probiotics
(LAB) are attributed to the bacteriocins produced by these bacteria in addition to other compounds such as lactic
acid, hydrogen peroxide, etc. While use of bacteriocins to control foodborne pathogens in swine has been
evaluated, studies focused on poultry use are limited.

Bacteriophages. These bacterial viruses often have limited or narrow host specificity and, therefore, can be used
to control specific microorganisms such as foodborne pathogens Salmonella and Campylobacter. The use of
bacteriophages to control disease-causing bacteria in poultry dates back to 1919, when d'Herelle used them as a
therapy for chicken typhus.6 The majority of the bacteriophages used for control of foodborne pathogens are lytic
phages, which infect the bacterial cell, replicate, and then destroy the bacterial cell. While some in vivo studies
have shown their efficacy in reducing Salmonella fecal colonization by > 4.2 log CFU within 24 hours, widespread
use in poultry production is limited. Research shows that use of phage cocktails prior to colonization of the birds
with Salmonella, the administration of numerous doses of bacteriophage cocktails, and the need for a proliferation
threshold (i.e., minimum level of bacteria concentration required to sustain a growing bacteriophage population)
are necessary for their efficacy.

Immunity Modulating Strategies (Vaccines)

The poultry sector has relied on vaccines to control the Salmonella-related poultry diseases pullorum disease and
fowl typhoid. These diseases have been practically eradicated in advanced countries through properly
implemented vaccination programs, surveillance, and proper biosecurity measures. The vaccines harness the
immune systems of the hosts to reduce Salmonella numbers upon infection, rather than controlling the disease. As
immunizing young chicks within the first week is not effective since their immune systems are not fully developed,
it is ideal to vaccinate the breeders to provide protective immunity to the progeny. This approach is used
extensively in the layer industry to control Salmonella Enteritidis in the layer flocks, and consequently mitigate the
Salmonella Enteritidis risk in the shell eggs.

All three Salmonella vaccine types—live-attenuated, inactivated, and sub-unit vaccines—are used in the broiler
industry. Although the majority of them are tailored for intramuscular or sub-cutaneous delivery, oral
immunization is probably the best delivery method in terms of ease of immunization of the birds, especially at the
commercial broiler grow-out level. Most poultry integrators utilization vaccination against specific or multiple
Salmonella serotypes or groups at the breeder level to avoid them at the hatchery and broiler grow-out and,
consequently, at the processing level and in poultry meat.

While in ovo vaccination, vaccinating the eggs to provide immunity to the chick after hatch is popular for poultry
viral pathogens (such as those that cause Marek's disease, infectious bursal disease, and fowl pox), vaccines for
Salmonella have not been developed and evaluated for this type of delivery. This delivery mechanism may be
valuable in controlling Salmonella in poultry as it presents the easier delivery of vaccine to the chicks, with the
ability to immunize greater than 70,000 eggs within a short period. Experimental advances in vaccine approaches
are encouraging for their increased efficacy and coverage.

Summary and Conclusions

In Part 1, we discussed the potential sources of Salmonella introduction into the poultry flocks and practical
control measures to address each of those sources to reduce the risk of Salmonella in broiler flocks. It is necessary
to control the sources of Salmonella introduction as much as possible, as relying only on subsequent measures will
not be adequate to reduce the risk, especially in the post-antibiotic period.

With such control measures implemented to reduce Salmonella introduction through the identified sources,
implementation of good biosecurity measures, along with a mixture of properly designed interventions outlined in
this article, will further reduce the risk of Salmonella through reduction in concentrations and/or prevalence of
Salmonella in and on the birds presented at slaughter. This is critical to address the challenges of further reducing
Salmonella prevalence in poultry meat and, consequently, Salmonella-related foodborne illness from chicken meat.

Part 3 of this article, to be published in the December/January issue, will focus on post-harvest controls during
processing to minimize the risk of Salmonella from poultry products.

References

1. Thippareddi, Harshavardhan and Manpreet Singh. "A Critical Look at Reducing the Risk of Salmonella in Poultry Products." Food Safety Magazine
August/September 2022. https://digitaledition.food-safety.com/august-september-2022/feature-spotlight/.

2. Fairchild, Brian D. and Dan L. Cunningham. "Biosecurity basics for poultry growers." University of Georgia Extension Bulletin no. 1306 (2020).
https://extension.uga.edu/publications/detail.html?number=B1306&title=Biosecurity Basics for Poultry Growers.

3. Dunn, L. L., V. Sharma, T. K. Chapin, L. M. Friedrich, C. C. Larson, C. Rodrigues, M. Jay-Russell, K. R. Schneider, and M. D. Danyluk. "The
prevalence and concentration of Salmonella enterica in poultry litter in the southern United States." PLOS One 17 (2022).

4. Adhikari, P., S. Yadav, D. E. Cosby, N. A. Cox, J. A. Jendza, and W. K. Kim. "Effect of organic acid mixture on growth performance and
Salmonella Typhimurium colonization in broiler chickens." Poultry Science 99 (2020): 2645–2649.

5. Fuller, R. "Probiotics in man and animals." Journal of Applied Bacteriology 66 (1989): 365–378.

6. Summers W.C. "Bacteriophage Therapy." Annual Review of Microbiology 55 (2001): 437–451.

7. Rossi, B., A. Toschi, A. Piva, and E. Grilli. "Single components of botanicals and nature-identical compounds as a non-antibiotic strategy to
ameliorate health status and improve performance in poultry and pigs." Nutrition Research Reviews 33, no. 2 (December 2020): 218–234.
https://pubmed.ncbi.nlm.nih.gov/32100670/.

Harshavardhan Thippareddi, Ph.D., is the John Bekkers Professor of Poultry Science in the Department of Poultry Science at the University of Georgia in
Athens, Georgia.

Manpreet Singh, Ph.D., is Professor and Head of the Department of Food Science and Technology at the University of Georgia in Athens, Georgia.

Todd Applegate, Ph.D., is the R. Harold and Patsy Harrison Chair in Poultry Science in the Department of Poultry Science at the University of Georgia in
Athens, Georgia.

Sudhir Yadav, Ph.D., is a Research Scientist and holds a doctorate from the Department of Poultry Science at the University of Georgia in Athens, Georgia.

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 > SPOTLIGHT

Video credit: visualspace/Creatas Video via Getty Images

Ongoing Improvements to Meat and Poultry Safety

The author examines five current topics in meat and poultry and their implications
to protein food
By Eric Wilhelmsen, Ph.D., C.F.S., Principal Consultant, Alliance of Technical Professionals

The meat and poultry industries are an interesting mix of conservative practices and innovation. A handful of
large players control the bulk of production; yet, numerous small players find their niches. Beef is king. Poultry
might be queen, but pork seafood are serious sectors in their own right. The rise of plant-based substitutes and
lab-cultured substitutes adds excitement and turmoil. Given this complexity, it is impossible to examine all aspects
of new developments in the wider meat and poultry sectors. This article examines five specific topics and their
implications to protein food:

1. Meat safety as a model for the produce industry

2. Increased interest in Salmonella 

3. Focus on Listeria monocytogenes 

4. The move toward aggregated sampling

5. Developing safety needs for lab-cultivated protein products.

Meat Safety as a Model for the Produce Industry

Periodically, the beef industry is used as an example to the produce industry of how to handle the presence of
pathogens. It appears that this comparison is again being promoted. Although it is tempting to accept the acclaim,
this comparison may not be ultimately beneficial if it is used to justify testing as the solution to the challenges in
produce.

The beef industry's response to the high incidence of hemolytic uremic syndrome (HUS) in 1993 is a case study
worthy of review. The details are not rehashed here; but it is important to note that the industry made many
changes in response to this event, including more intense testing for Escherichia coli O157:H7. Many attribute the
recovery of the beef industry to this increase in testing. This may be a naïve position, as the importance of
mitigation steps cannot be overstated. Process improvement is always more effective mitigation than testing.

Despite of these efforts, the beef industry continues to experience recalls. The common N = 60 and N = 60+ testing
have a limit of detection (LOD) of about 3 CFU/pound if the sample is assumed to be random (i.e., truly
representative). Given that heterogeneity is likely, this standard for sampling is probably not met. If the meat were
not largely cooked, this limit of detection would not provide a reasonable level of safety. Instead, it offers the beef
industry a reasonable metric for monitoring process performance. E. coli O157:H7 is viewed as an adulterant that
contaminates meat during slaughter. U.S. Department of Agriculture (USDA) prescriptive controls promote safe
beef to the customer, and USDA cooperates with industry with inspectors in the plants to make this happen.

In contrast, the produce industry and leafy greens processors, in particular, are struggling with outbreaks caused
by contamination levels that are lower and, in many cases, much lower than the beef industry's LOD. The produce
industry faces the more adversarial regulation by the U.S. Food and Drug Administration (FDA) with a zero
tolerance for pathogens. An expert panel estimated that the severe outbreak associated with romaine lettuce in
2018 was caused by contamination at an average of 1 CFU/pound over 50 acres. Additionally, the problem in
produce is environmental and not the direct result of processing steps, unless an error occurs.

The levels of pathogen control targeted in the produce industry are not presently practical in meat production.
Increased testing can only provide assessment, and will not function successfully as a mitigation. Given the much
lower value of the raw commodity and the lower contamination rates, increased testing is not economically
feasible. Any comparisons between meat production and produce production with regard to food safety must take
into account the many differences in the sectors. This situation is clearly one where each industry should stay in
its own lane.

Increased Interest in Salmonella

USDA's Food Safety and Inspection Service (FSIS) recently declared Salmonella to be an adulterant in breaded and
stuffed raw chicken products, paving the way for future action in line with FSIS' broader efforts to reduce
Salmonella illnesses associated with poultry. However, FSIS also denied a petition filed by Marler Clark LLC asking
the agency to declare 31 serotypes of Salmonella as adulterants in meat and poultry products. The pace and scope
of future legislative action by USDA to address Salmonella in meat and poultry remains to be seen.

FSIS has a role to promote U.S. agriculture. Regulating these 31 serotypes of Salmonella as adulterants would have
many far-reaching consequences. The agency asserts that it "does not believe that there is sufficient data available
at this time to support the sweeping actions requested" in the Marler Clark LLC petition. The petition was rejected
without prejudice, however, meaning that it can come back with new or improved data.

Meat products, particularly poultry, have been implicated in many salmonellosis events each year. At question is
whether Salmonella should be considered an adulterant as an "added substance" that "may render injurious" a food
contaminated with it, or if the pathogen should continue to be regarded as a "naturally occurring" substance. The
contention is that Salmonella is ordinarily injurious in all meat and poultry products regulated by FSIS. Although
the agency traditionally has considered Salmonella as naturally occurring in food animals, USDA appears to be
reassessing this interpretation and considering whether the pathogen should be deemed an adulterant in any
poultry product.

The analytical aspects of Salmonella contamination are daunting. Not all Salmonella are equally virulent.
Determining virulence factors will be important to guidance and regulation. Simple presence/absence testing for
Salmonella spp. is straightforward with modern molecular methods, but such testing could force the diversion of
substantial portions of product to cooked applications. Applying such a testing requirement would burden beef,
pork, and poultry differently. Beef positives are lowest, probably due to the extensive efforts to control E. coli
O157:H7. Pork testing finds more positives, but still fewer than poultry. These differences make guidance and
regulation more complicated. It is difficult to justify setting different levels of tolerance in these three categories
of meat if Salmonella were to be declared an adulterant more generally.

USDA is reported to have selected bioMérieux's GENE-UP QUANT as its method of choice for
Salmonella enumeration in USDA food safety inspection service labs. This test is reported to deliver quantification
results in less than four hours across matrices, removing incubation and growth biases. This raises the question if
quantitative tolerances for Salmonella, rather than a presence/absence standard, will be accepted.

Salmonella performance standards have been established to encourage companies to take action to reduce
Salmonella in their products. Performance standards hold the industry responsible for maintaining control of
pathogens and implementing best practices and intervention technologies to keep their products safe for
consumers. Recently, the comment period closed regarding changes to the performance standard for pork
products. USDA appears to be committed to continue down this path and continues to collect scientific data and
information. The protein food industry can anticipate more opportunities for comment as USDA continues to fine-
tune this effort.

USDA seems to have started the process of issuing new regulations for Salmonella in both poultry and pork. New
testing requirements are expected in both these industries, stemming from this increased regulation. USDA
researchers are actively engaged in validation testing of aggregated sampling techniques that are expected to be
included in these regulations. The data collection process for validation is underway at major U.S. meat and
poultry producers.

"Revisions to 9 CFR 430.4 reflect changes to clarify that

establishments may not release into commerce product that has
tested positive for Listeria without reprocessing the product."
Focus on Listeria monocytogenes

FSIS verification of establishment compliance with Listeria controls is considered to be an important food safety
verification activity by FSIS. In March 2022, the directive on Listeria verification activities was updated to provide
revised instructions for verifying that meat and poultry establishments are in compliance with the regulatory
requirements of 9 CFR 430.4, Control of Listeria in Post-Lethality Exposed Ready-to-Eat Products (the
"Listeria Rule"). The revisions reflect changes to clarify that establishments may not release into commerce
product that has tested positive for Listeria without reprocessing the product (80 FR 35178). The directive also
notes required compliance for products that are not post-lethality exposed (e.g., cook-in-bag), in response to
several recent outbreaks implicating products that were incorrectly classified as not post-lethality exposed.

This directive is very prescriptive and provides a safe harbor using Standard Sanitation Operating Procedures
(SSOPs) and Hazard Analysis and Critical Control Points (HACCP) for preventing post-lethality contamination of
RTE meat products. According to the Listeria Rule, establishments producing post-lethality exposed RTE products
must comply with the requirements included in one of the Listeria Control Alternatives to prevent adulteration.
Clearly, sanitation is critical to control Listeria in processing facilities. It is reasonable to expect further changes in
this area as long as there are outbreaks and recalls. The recent beef jerky event will provide further incentives for
FSIS to adjust how facilities control Listeria.

The Move toward Aggregated Sampling

The foundational concepts of aggregated sampling are not new. However, the use of non-woven polyolefin swabs
as introduced by lead inventors, Thomas Wheeler and Terrence Arthur of USDA, has led to widespread adoption
for the testing of beef trims. Patented sampling swabs utilize this aggregated sampling approach in both a manual
method and in a continuous sampling method.

Based on the FSIS letter of no objection and the validation efforts of Wheeler and Arthur, this aggregated
sampling approach is displacing the N = 60 and N = 60+ techniques based on tissue excision. The aggregated
sampling technique is preferred because no sharp implements are involved, less growth media is required, less
hazardous waste is produced, and labor savings are obtained. The IAFP 2022 symposium, "Non-Destructive
Superior Sampling," detailed the benefits of this method.1

This trend in sampling is expected to expand into the sampling of poultry and pork, where trials are already
underway. The U.S. patent for the sampling swabs presents additional opportunities, including the use of a
pocketed sampling device or mitt, which will meet industry needs in these other meat categories. Some validation
work still needs to be done, but it is likely that these sampling devices will be included in future guidance on
sampling.

Developing Safety Needs for Lab-Cultivated Protein Products

Tissue culture is the latest approach to providing protein food. Recently, plant-based protein food made large
gains in consumer acceptance. The technologies behind these improvements will help tissue culture-based
competitors gain consumer acceptance with desirable textures and forms. The tissue culture-based category is too
new to have a clear understanding of the specific safety challenges. The only certainty is that there will be
challenges.

The situation for tissue-culture based products is unique among protein foods. The starting material must be free
of contaminating bacteria due to the requirements for incubation and growth of the desired cells. This contrasts
with the protein from plants and the protein harvested from animals, which are known to contain some level of
pathogens. This difference will likely prompt claims of being "inherently safe." These kinds of claims have been
made about controlled environment agriculture (CEA) for produce; however, CEA has already seen its first food
safety-related recalls. Tissue-culture protein foods will not be inherently safe.

The position of regulators, at present, is that current guidance for Good Manufacturing Practices (GMPs) and
sanitation are sufficient. Hopefully, the practitioners of tissue-culture meat production will adapt to the
differences in fabricating food and smoothly transition to these different requirements and any updates or
revisions, as necessary. This adaptation may require hiring outside food safety expertise.

Change is good when it is part of a continuous improvement effort. Protein foods have experienced some major
changes. When the dust settles, it is hoped that consumers will have some additional safe protein options.

References

1. Arthur, Terrance, Daniel DeMarco, and Eric Wilhelmsen. "Non-Destructive Superior Sampling." Presented at the IAFP 2022 Annual Meeting.
August 1, 2022, Pittsburgh, Pennsylvania.

Eric Wilhelmsen, Ph.D., C.F.S., is a recognized world authority in food authentication, serving for over 25 years in both academic and industrial positions.
In these roles, he has provided technical leadership and innovation for industrial collaborations. His technical contributions and practical innovations have
been fundamental in establishing new revenue streams and profitable businesses in juices, dietary supplements and botanicals, agricultural commodities,
byproducts, and beverages. He can be reached at the Alliance of Technical Professionals: eric.wilhelmsen@atpconsultants.com.

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

PROCESS CONTROL
By Martin Bucknavage, M.B.A., M.S., Senior Food Safety Extension Associate, Penn State Department of Food Science and Member, Food Safety
Preventive Controls Alliance Executive Board; and Kathy Gombas, Food Safety Consultant, FSMA Solutions and Chair, Food Safety Preventive
Controls Alliance Executive Advisory Board

SCROLL DOWN

Reanalysis—A Critical
Component of Verification 
The Food Safety Plan/HACCP Plan is a living document
that requires ongoing maintenance, including
reanalysis at appropriate time intervals
Photo credit: Sunan Wongsa-nga/iStock / Getty Images Plus via Getty Images

A Hazard Analysis and Critical Control Points (HACCP)-based program is not a document that is simply written
and forgotten. Changes occur over time, whether those are related to the facility, the process, or the ingredients.
In addition, collective knowledge about science and technology improves; for example, the survivability of a given
pathogen under certain processing conditions or the effects of climate change (drought) on increased incidence of
mycotoxin hazards in raw agricultural commodities. Due to these factors, a company's Food Safety Plan/HACCP
Plan ("the plan") must adapt to reflect these ongoing changes and any new information. This is where reanalysis
comes in. Reanalysis is a critical component of the verification principle where the plan is reviewed to ensure that
it is accurate and applicable, and that it reflects change and improved understanding. Reanalysis activities also
incorporate the review of records to identify trends.

When the time comes to reanalyze the plan, this process needs to be more than a "rubber-stamping" of the current
plan; it needs to be a chance to truly confirm that the plan is working and is sufficient to control the identified
hazards. Within this process, it must be ensured that all required documentation is present including validation
support and process records. It is reaffirmed that all hazards have been identified, that appropriate controls are in
place for these identified hazards, and that these controls are performing as intended.

One issue is that, too often, the reanalysis process is not considered until the last minute, when it is time to
conduct that activity due to a regulatory deadline or third-party audit requirement. Reanalysis should occur at a
frequency that ensures the plan is being followed continuously. For the reanalysis process to be most effective, it
should be part of an ongoing process of gathering information from internal sources, as well as external sources.
One should not wait passively for that stated time to pass to review the plan, but instead look for signs and trends
that indicate when a review is needed.

Internally, it is recommended to look at all changes to raw materials, process, and product, as well as indicators
that something may be going awry. Externally, it is recommended to look at information involving suppliers, other
companies processing the same or similar products, and the broader industry. It is important to follow
developments in science that address the ingredients and processes used and the advances in understanding of the
associated hazards. If this ongoing activity becomes part of a normal review regiment, then the reanalysis process
will be more fruitful, occurring when it needs to rather than coming about as just a "check-off" item to meet
regulatory or third-party audit time requirements.

“At a minimum, a plan should be reviewed at a set frequency

selected by the company, but often is determined by regulatory
or third-party audit requirements.”

Reanalysis is One Component of Verification 

Verification, a key principle within the HACCP-based program, is the application of methods, procedures, tests,
and other evaluations, in addition to monitoring, that determine: 1) the validity of the plan, and 2) that the system
is operating according to the plan. Think of verification as an umbrella with three key components underneath the
umbrella:

1. Verification of implementation and effectiveness—e.g., review of monitoring, corrective action, and

verification records; calibration of process monitoring equipment; and product testing

2. Validation, the component of verification focused on collecting and evaluating scientific and technical
information to determine if the Critical Control Point (CCP) or Process Preventive Control can effectively
control the identified hazard when the plan has been properly implemented

3. Reanalysis of the Food Safety Plan.

The activities involved with the first verification component occur frequently, such as ensuring daily compliance of
process controls (e.g., calibration, record review, and product testing). This ensures that the plan is working as it
was designed. The second component, validation, establishes the scientific basis for the CCP or Process Preventive
Control in the plan utilizing scientific principles and data, expert opinion, or challenge studies and is typically
conducted before the Food Safety Plan is implemented and whenever changes occur that would impact the efficacy
of the process control. The third component, reanalysis of the Food Safety Plan, is the review of the overall plan
for compliance. This not only ensures the plan is being implemented properly, but also gives the chance to review
whether the elements of the plan are correct. Reanalysis, by definition, is "a verification procedure to assure that
the Food Safety Plan remains valid and the food safety system is operating according to the plan."1

When is reanalysis started? At a minimum, a plan should be reviewed at a set frequency selected by the company,
but often is determined by regulatory or third-party audit requirements. Since regulatory requirements for
reanalysis can be one to three years, it is advisable that more frequent reanalysis be conducted. Certain situations
should also trigger a reanalysis:

A significant change in the process or other activities conducted within the facility that impact the
control of the hazard or increase the likelihood of a new hazard

Changes in raw materials or suppliers

Adverse findings obtained in monitoring or verification activities

New information about potential hazards associated with the food

Changes in downstream supply chain practices—distribution, further processing, or sales

New consumer practices

If the plan or a control is found to be ineffective.

Any significant changes to the process require, at a minimum, a review to determine whether these changes have
impacted parameters that can affect the safety of the product. If new information is gained about a pathogen—
perhaps its ability to survive under conditions similar to those used in the process—or if a supplier is involved in a
recall, then this may necessitate a reanalysis. This reanalysis will help determine if these changes (or new
information) have impacted our understanding of control detailed in the hazard analysis.

Without any change or new information, the plan can be reviewed at regular time intervals. Industry practice
dictates that reanalysis be completed at least yearly. As part of regulatory requirements, there are also regulated
timeframes for reanalysis. For the U.S. Food and Drug Administration's (FDA's) Preventive Controls for Human
Foods regulation, reanalysis must occur at least every three years [21 CRF 117.170(a)]. FDA's Seafood and Juice
HACCP regulations and USDA's HACCP regulation require a yearly reanalysis.

Reanalysis in Response to Change in Ingredient, Process, or Product

It may be difficult to know when a change will be significant enough to impact the safety of the process or product.
Therefore, it is best to have a procedure in place to review all changes in terms of their impact on the Food Safety
Plan. The organization must be disciplined in following these procedures regardless of whether some initially
perceive these changes as small or insignificant. The procedures must require that the changes are reviewed prior
to being made.

Looking at this from a flow-of-food perspective, any changes to the ingredients and the suppliers of those
ingredients must be addressed. This may involve the use of a new supplier of a given ingredient and/or changes to
the ingredient itself, whether that be in the formulation of the ingredient or its processing. It can include a change
in the supplier's operation—e.g., the supplier has introduced a novel allergen into its operation. It can also include
a change in a supplier's supplier of an ingredient.

Similar changes can occur in one's own facility, including changes to formulation, processing, equipment,
packaging, and storage. The addition of novel allergens or allergen combinations can affect production run cycles
and sanitation, as well as labeling operations, so this must be carefully reviewed. In addition, the relocation of
equipment may impact the ability of the unit to perform correctly—e.g., moving a metal detector from before the
product freezing step to after the freezing step may impact the detector's sensitivity and ability to detect metal,
due to changes in the composition of the product.

Looking downstream in the flow of food, changes to distribution practices must be evaluated—e.g., storage or
downstream processing, where new conditions can expose hazards that had not been viewed as a risk under the
previous evaluation. For example, if product had been shipped and kept frozen to the point of processing, but now
the product is thawed under refrigeration for a period of several days prior to processing, then the opportunity for
pathogen growth may emerge, especially in the case of temperature fluctuations during storage.

Utilizing a mandatory review process for these expected changes can help better identify potential risks before the
change is made, and the risk can continue to be evaluated after the change has been made. Without such a review
process, the determination of risk is often left to the person or people who are making the change. There are
several problems with this. For one, this person may not have the level of knowledge needed, or they may be
willing to forgo an in-depth review (i.e., hazard analysis) to expedite the change. In some cases, the person may
take it upon themselves to decide that the change is insignificant and that there is no need for further review. For
example, the maintenance manager may decide that moving the metal detector after the freezer is an insignificant
change, and not realize that the detector would need to be recalibrated for frozen food conditions.

Having changes reviewed by a team, at the very least, ensures that the facility's most qualified individuals have a
chance to review them. Involving more than one person in this analysis ensures that more than one point of view
will be considered.

“An ongoing, in-depth analysis of process data and other related

information must be in place not only to look for potential
issues, but also to identify indicators that potential issues may
exist.”

Ongoing Evaluation of the Process and Associated Parameters

Processes can vary over time, often related to equipment wear, new employees, laxation of procedures, etc.
Increases in process variability can then result in loss of control and suspect product produced. Therefore, an
ongoing, in-depth analysis of process data and other related information must be in place not only to look for
potential issues, but also to identify indicators that potential issues may exist.

Recurring adverse findings are a sure sign that something is not right. An adverse finding is not limited to process
deviations where a critical limit is not met, although that certainly necessitates reanalysis. Adverse findings
include indicators that signal increased process variation, or data trending toward the point of deviation. In these
cases, because a deviation has not occurred, the same attention may not be given to the deviation from a critical
limit. However, this should not rule out the need for conducting a reanalysis. The goal here is to determine and
correct the process before the critical limit is violated.

Adverse findings can be related to product testing results that are slightly out of specification. For example,
higher-than-normal microbial levels discovered through testing could be indicative of something amiss within the
process. If standard bacterial counts begin to climb, what does this say about the process or the process
environment? It may not yet indicate that product must be held, but it should not exclude the need for reanalysis.
Another example is detection of metal in a product and conducting an immediate investigation of the root cause,
instead of waiting for the scheduled reanalysis date.

Consumer complaints is another parameter that should receive regular and careful review. Are trends emerging in
the types of complaints received? Is a root cause analysis completed for complaints that may have a more serious
nature? Are trends evident within the consumer complaint data?

Ongoing evaluation of these various parameters cannot be happenstance; rather, they must be part of the regular
evaluation routine.

External Evaluation for New Information

In addition to evaluating internal data, the evaluation of external information must be part of a routine review.
Recalls, outbreaks, and FDA warning letters are a few obvious sources of information that should be reviewed on a
regular basis. Additional information sources include reviews of scientific literature, especially concerning similar
processes and types of hazards, as well as less scientific sources of information such as social media.

Tracking food safety issues throughout the industry provides information that may have a direct bearing on one's
own operation. For example, a recall that was linked to a similar ingredient or process used by one's own company
should be a red flag. In this case, one would want to investigate this issue further to understand what implications
this may have on their facility.

New information, such as a published article in a scientific journal, regarding similar hazards or control measures
may also trigger reanalysis efforts. If a published study finds that a pathogen has increased heat resistance under
certain situations, and this pathogen had been identified in a hazard analysis by one's own company, does this
information have any bearing on one's control over this pathogen?

New consumer handling or preparation practices may also trigger the need for reanalysis. Consumers are
constantly finding new ways to use food products, including ways that were not intended by the manufacturer.
These new uses are often perpetuated to wider adoption through social media channels, so that even more
consumers are using these novel—and potentially more risky—practices.

A great example is the use of various frozen foods in making smoothie drinks. While the intent of the
manufacturer of that frozen food, as detailed in the cooking instructions, was to have that product fully cooked,
consumers are adding the frozen food directly to the blender to be consumed without any further processing.
What impact does a novel practice have on these products, and how is that reflected in the hazard analysis?

“The Food Safety Plan/HACCP Plan is a living document. It

requires ongoing maintenance to ensure that the plan adapts to
change.”

A Reason to Reanalyze Now—Post-COVID Impacts

In the post-COVID-19 environment, there are many compounding factors that impact the need to conduct a
reanalysis. While information may not indicate the need to conduct a reanalysis, it may be a good idea to make
sure that the operation has a full understanding of current processes and procedures.

High turnover of personnel (whether that be the quality manager or technical staff ) may lead to a situation where
new personnel are not fully aware of the plan details. Conducting a reanalysis before there is an immediate need
to conduct a reanalysis may provide an opportunity for new personnel to gain an understanding of the plan, where
the documents are stored, what types of process validation exist, etc.

In this post-COVID-19 environment, the food supply chain has been severely impacted. As a result, many changes
may have gone unnoticed. In some cases, regulatory labeling requirements were relaxed. Purchasing managers
have been forced to become nimbler in getting supplies to keep plants running and may have utilized alternative
sources of materials, or their suppliers may have found alternative suppliers. A reanalysis may provide the
opportunity to review changes that could have impacted the supply chain.

The Food Safety Plan/HACCP Plan is a living document. It requires ongoing maintenance to ensure that the plan
adapts to change. Reanalysis is the process by which the plan is ensured to remain valid, and the food safety
system is ensured to be operating according to the plan. For this process to be most successful, it requires an
active review of internal information that includes changes to process and product, as well as data related to
process variation, product testing, and consumer complaints. A process for reviewing external information (both
scientific and social) must also be in place.

References

1. Food Safety Preventive Controls Alliance. "Preventive Controls for Human Foods Training Curriculum." V1.2, First Edition, February 2016.

Martin Bucknavage, M.B.A., M.S., is the Senior Food Safety Extension Associate with the Penn State Department of Food Science and a member of Food
Safety Preventive Controls Alliance Executive Advisory Board.

Kathy Gombas is a Food Safety Consultant with FSMA Solutions and Chair of the Food Safety Preventive Controls Alliance Executive Advisory Board. Kathy
was formerly a Senior Advisor with the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN).

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

PACKAGING
By George G. Misko, Esq., Keller and Heckman LLP
SCROLL DOWN

Navigating U.S. Federal and

State Regulation of PFAS in
Applications Involving Food  
PFAS restrictions and bans are not consistent, and
determining compliance presents numerous challenges
Photo credit: thesomegirl/iStock / Getty Images Plus via Getty Images

As the focus on per- and polyfluoroalkyl substances (PFAS) intensifies, multiple states and some U.S. federal
agencies are implementing or considering implementation of restrictions or bans on the use of these products in
food contact articles. The problem for food companies and suppliers to the industry is that these restrictions and
bans are not consistent and, therefore, determining compliance presents numerous challenges.

This article focuses on the restrictions and bans in the U.S. that impact the use of PFAS in food packaging, and
includes a discussion of the challenges manufacturers face due to inconsistent science and policy decisions related
to the use of these chemicals in food packaging. It is important to note that food-contact materials are only one
source of PFAS. They have also long been used in fire extinguishing foam; in stain and water-repellent materials
used on clothing, upholstery, and other fabrics and textiles; and in personal care products, such as certain
shampoos, dental floss, and cosmetics. Due to this widespread use, PFAS have been found in soil and water at or
near waste sites and manufacturing or chemical production facilities that use or produce PFAS.

PFAS Lack Universal Definition

PFAS are a diverse group of synthetic chemicals with strong carbon-fluorine bonds that are chemically inert and
resistant to high temperatures. They are often referred to as "forever chemicals" due to their biopersistence.
Importantly, there is not a universally agreed-upon definition for PFAS. For example, the Environmental
Protection Agency (EPA) defines PFAS as "chemicals with at least two adjacent carbon atoms, where one carbon is
fully fluorinated and the other is at least partially fluorinated."1 Alternatively, the Organization for Economic
Cooperation and Development (OECD) defines PFAS as consisting of "fluorinated substances that contain at least
one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it); i.e., with a few
noted exceptions, any chemical with at least a perfluorinated methyl group (-CF3) or a perfluorinated methylene
group (-CF2-) is a PFAS."2

Some groups argue that EPA's definition of PFAS is too narrow. One of these groups, the Public Employees for
Environmental Responsibility (PEER), filed a lawsuit against EPA in the U.S. District Court for the District of
Columbia claiming that the agency is "withholding documents explaining why [EPA] has adopted an exceedingly
limited definition of per- and polyfluoroalkyl substances (PFAS)."3

In addition, a bipartisan bill (H.R. 5987)4 pending in the House of Representatives would amend the Toxic
Substances Control Act (TSCA) by expanding the definition of PFAS to include substances that contain at least one
fully fluorinated carbon atom. No action has been taken on this bill since it was referred to the Subcommittee on
Environmental and Climate Change on November 17, 2021. However, several recently enacted state laws use
exactly this definition.

Despite the varying definitions, not all PFAS are the same and, therefore, many argue that they should not be
regulated in the same way. Different PFAS are treated differently by EPA, the U.S. Food and Drug Administration
(FDA), and certain other regulatory bodies. As FDA points out, "[w]ithin PFAS there is a wide range of chemical
structures with very different chemical and physical properties."5

EPA explains that, "exposure to some PFAS in the environment may be linked to harmful health effects in humans
and animals," but adds, "[t]here are thousands of PFAS chemicals… mak[ing] it challenging to study and assess the
potential human health and environmental risks."6 The agency further explains that each of the PFAS chemicals
has varying toxicity. "Robust information about PFAS is needed to better understand the risks they pose and to be
able to take effective actions to protect human health and the environment," states EPA on its website.7

Recently, a panel of scientists with expertise on PFAS technology agreed to the following:

All PFAS should not be grouped together for risk assessment purposes

"Persistence" is not sufficient for grouping PFAS for the purposes of assessing human health risk

It is inappropriate to assume equal toxicity/potency for all PFAS compounds without confirmatory
information.8

Federal Agencies Take Action on PFAS

Based on new scientific studies indicating the potential for negative health effects with perfluorooctanoic acid
(PFOA) and perfluorooctane sulfonic acid (PFOS) (so-called long-chain PFAS), EPA issued interim updated lifetime
drinking water health advisories (HAs) of 0.004 part per trillion (ppt) and 0.02 ppt, respectively, on June 15, 2022.
The agency stated that lifetime exposure to PFOA and PFOS can compromise the immune and cardiovascular
systems and are linked to decreased birth weights.9 (The previous levels were 70 ppt for both chemicals.10)

At the same time EPA issued HAs for PFOA and PFOS, the agency also issued final health advisories for
perfluorobutanesulfonic acid (2,000 ppt) and what are known as GenX chemicals (10 ppt), which to some extent
may be used as replacements for PFOS and PFOA, respectively.

On the food side, since the 1960s FDA has authorized the use of certain PFAS in specific food-contact applications.
PFAS compounds authorized for use in contact with food generally fall into four applications categories:

Non-stick cookware

Gaskets, O-rings, and other parts used in food processing equipment

Processing aids for the production of food contact polymers to reduce buildup on manufacturing
equipment

Paper/paperboard food packaging for use as grease-proofing agents.12

In the early 2000s, when new scientific studies raised safety questions with long-chain C8 PFAS compounds (i.e.,
PFOA and PFOS), FDA worked with several manufacturers to voluntarily stop their sales of grease-proofing agents
containing C8 compounds for use in food contact applications in the U.S. market. In 2016, FDA revoked the
regulations authorizing the remaining uses of these long-chain PFAS in food packaging.12 Interestingly, the basis
for the revocation was U.S. industry's "abandonment" of the technology—i.e., the cessation of the compounds' uses
in the U.S.—rather than a negative safety evaluation.

When additional studies became available to FDA indicating biopersistence issues with certain short-chain PFAS
that contain 6:2 fluorotelomer alcohol (6:2 FTOH) used for grease-proofing in paper and paperboard for food
packaging, FDA announced a voluntary phase-out by the manufacturers of these products.14 Three manufacturers
voluntarily agreed in July 2020 to a three-year phase-out of sales of these compounds for use in food contact
applications in the U.S., beginning in January 2021. After the three-year period, it is anticipated that it may take
up to 18 months to exhaust existing stocks of products containing these food contact substances. Another
manufacturer had already informed FDA in 2019 that it had stopped sales of its products containing 6:2 FTOH in
the U.S. market.

Finally, FDA issued a request for information on the use of fluorinated high-density polyethylene (HDPE)
containers for food-contact applications.14 These containers are cleared by FDA in 21 C.F.R. § 177.1615. Specific
information that FDA requested includes current food-contact uses, manufacturing conditions, analyses of the
migrating substances from the containers, estimated consumer exposure, and safety of fluorinated polyethylene.
Comments are requested to be submitted by October 18, 2022.

“To better understand the potential dietary exposure to PFAS

from food for people in the U.S., FDA began testing foods
collected as part of its Total Diet Study for certain PFAS in 2019.”

FDA Tests for PFAS in Food

To better understand the potential dietary exposure to PFAS from food for people in the U.S., FDA began testing
foods collected as part of its Total Diet Study (TDS)15 for certain PFAS in 2019. The results did not show
widespread presence of PFAS at detectable levels in the food products sampled, ranging from a low of one finding
in 94 samples to three in 92 samples.16 In a February 2022 announcement on the results of the sample testing,
FDA stated, "Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS
found in the TDS samples tested to date indicate a need to avoid any particular food."17

More recently, FDA announced in July of this year that it had tested 81 samples of clams, cod, crab, pollock,
salmon, shrimp, tuna, and tilapia imported from China, from which it determined that estimated exposure to
PFOA from samples of canned clams were likely a potential health concern. FDA explained, "For the canned clam
samples with the two highest levels of PFOA, there would be a potential health concern for consumers who eat
more than approximately 10 ounces (oz) of these clams per month, except for young children, who should limit
consumption to 2 oz per month."18

The two distributors of the samples with the highest levels of PFOA issued voluntary recalls of the product. FDA
said that it is working with distributors of canned clam product to better understand potential sources of
contamination.

FDA looks at a number of factors to determine possible human health concerns from substances, such as whether
there is an established action level or tolerance, how much of the specific food people typically eat, the level of the
contaminant detected in that food, and the toxicity of the specific contaminant(s).

PFAS Bans and Restrictions Imposed by States

A number of states have enacted PFAS bans in food packaging. All of these states define PFAS as a class of
fluorinated organic chemicals containing at least one fully fluorinated carbon atom. Washington and Maine were
the first states to lead the charge on banning PFAS in food packaging. Notably, both required alternative
assessments by the state before specific uses could be banned. Based on assessments completed so far,
Washington has scheduled PFAS bans in the following products for all food service items, scheduled for the noted
dates: as of February 2023, wraps and liners, plates, food boats, and pizza boxes; and as of May 2024, bags and
sleeves (made from flexible material), bowls, flat service ware (such as trays and plates), open-top containers, and
closed containers.

Below is a list of states that have subsequently enacted bans, none of which require an alternative assessment.

California (January 1, 2023): Bans the sale of "plant fiber-based food packaging" that contains PFAS that
have been intentionally added to have a functional or technical effect in the product or is present in the
product at or above 100 ppm.

Colorado (January 1, 2024): Bans any paper-based food packaging with intentionally added PFAS.

Connecticut (December 31, 2023): Bans food packaging to which PFAS have been intentionally
introduced during manufacturing or distribution, and prohibits substituting any component that creates a
hazard as great as or greater than PFAS.

Maryland (January 1, 2024): Bans a manufacturer or distributor from manufacturing or knowingly

selling, offering for sale, or distributing for sale or use in the state a food package or food packaging
component designed and intended for direct food contact to which PFAS chemicals were intentionally
added.

Minnesota (January 1, 2024): Bans food packaging containing intentionally added PFAS.

New York (December 31, 2022): Bans the distribution and sale of food packaging containing PFAS as
intentionally added chemicals.

Rhode Island (January 1, 2024): Bans food packaging to which PFAS have been intentionally introduced
during manufacturing or distribution.

Vermont (July 1, 2023): Bans the sale, distribution for sale, and distribution for use of any food package
to which PFAS have been intentionally added or are present in any amount.

The Rhode Island law also specifies, "The use of a regulated chemical as a processing agent, mold release agent, or
intermediate is considered intentional introduction… where the regulated chemical is detected in the final package
or packaging component." However, FDA maintains that, "the amount of PFAS used as processing aids in the
manufacture of other food contact polymers is so small that a negligible amount of PFAS is capable of migrating to
food from this use."11

Numerous other states—including Alaska, Arizona, California, Colorado, New Jersey, Pennsylvania, and Virginia—
are considering PFAS bans.

Congress Introduces Bill to Ban PFAS in Food Packaging

On June 14, 2022, the Keep Food Containers Safe from PFAS Act19 was passed as an amendment to the FDA Safety
and Landmark Advancements (FDASLA) Act of 2022 (S.4348)20 on a bipartisan vote (13–9) in the Senate
Committee on Health, Education, Labor, and Pensions. The amendment would ban the use of PFAS in food
packaging effective January 1, 2024.

Takeaway

Thousands of PFAS chemicals can be found for a wide variety of uses in different consumer, commercial, and
industrial products. Not all of these substances are of the same chemistry or necessarily similar toxicology. Some
may have applications that are intended primarily for consumer convenience or enhancement of certain product
qualities, while others may be critical to the production of goods or the delivery of services that are crucial to
maintaining health and safety. Thus, it is challenging, to say the least, to assess the potential human health and
environmental risks of these various PFAS, particularly in regard to the risks that may be presented against the
benefits that are provided.1 

However, if the states keep moving in the direction in which several have started, then these assessments may be
stunted. Precipitous decisions at this level may result in the premature retirement of many of these products and
product applications without adequate consideration of the existence of substitutes or the health and safety
benefits that may be lost.

References

1. U.S. Environmental Protection Agency (EPA). "National PFAS Testing Strategy: Identification of Candidate Per- and Poly-fluoroalkyl Substances
(PFAS) for Testing." October 2021. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/national-pfas-testing-strategy.

2. Organization for Economic Cooperation and Development. "Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances:
Recommendations and Practical Guidance." Series on Risk Management No. 61. July 9, 2021.
https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/CBC/MONO(2021)25&docLanguage=En.

3. "EPA Sued Over Failure to Explain Its Narrow PFAS Definition." Public Employees for Environmental Responsibility. April 28, 2022.
https://peer.org/epa-sued-over-failure-to-explain-its-narrow-pfas-definition/.

4. Congress.gov. "H.R.5987—117th Congress (2021–2022): PFAS Definition Improvement Act." November 17, 2021.
https://www.congress.gov/bill/117th-congress/house-bill/5987?r=52&s=1.

5. U.S. Food and Drug Administration (FDA). "Questions and Answers on PFAS in Food." July 6, 2022. https://www.fda.gov/food/chemical-
contaminants-food/questions-and-answers-pfas-food.

6. EPA. "PFAS Explained." April 28, 2022. https://www.epa.gov/pfas/pfas-explained.

7. EPA. "Increasing Our Understanding of the Health Risks from PFAS and How to Address Them." November 3, 2021.
https://www.epa.gov/pfas/increasing-our-understanding-health-risks-pfas-and-how-address-them.

8. Anderson, J.K., et al. "Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts." Regulatory Toxicology
and Pharmacology. July 8, 2022.

9. EPA. "Drinking Water Health Advisories for PFOA and PFOS." July 12, 2022. https://www.epa.gov/sdwa/drinking-water-health-advisories-pfoa-
and-pfos.

10. 81 Federal Register 83672. "Indirect Food Additives: Paper and Paperboard Components." November 22, 2016.
https://www.govinfo.gov/app/details/FR-2016-11-22/2016-28116.

11. FDA. "Authorized Uses of PFAS in Food Contact Applications." February 24, 2022. https://www.fda.gov/food/chemical-contaminants-
food/authorized-uses-pfas-food-contact-applications.

12. 81 Federal Register 5, January 4, 2016 and 81 Federal Register 83672, November 22, 2016.

13. FDA. "FDA Announces the Voluntary Phase-Out by Industry of Certain PFAS Used in Food Packaging." July 31, 2020.
https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-voluntary-phase-out-industry-certain-pfas-used-food-packaging.

14. 87 Federal Register 43274, July 20, 2022.

15. FDA. FDA Total Diet Study (TDS). July 15, 2022. https://www.fda.gov/food/science-research-food/fda-total-diet-study-tds.

16. FDA. "Analytical Results of Testing Food for PFAS from Environmental Contamination." July 6, 2022. https://www.fda.gov/food/chemical-
contaminants-food/analytical-results-testing-food-pfas-environmental-contamination.

17. FDA. "Update on FDA's Continuing Efforts to Understand and Reduce Exposure to PFAS from Foods." February 24, 2022.
https://www.fda.gov/food/cfsan-constituent-updates/update-fdas-continuing-efforts-understand-and-reduce-exposure-pfas-foods.

18. FDA. "FDA Shares Results on PFAS Testing in Seafood." July 15, 2022. https://www.fda.gov/food/cfsan-constituent-updates/fda-shares-results-
pfas-testing-seafood.

19. Congress.gov. "Text—S.3169—117th Congress (2021–2022): Keep Food Containers Safe from PFAS Act of 2021." November 4, 2021.
https://www.congress.gov/bill/117th-congress/senate-bill/3169/text.

20. Congress.gov. "S.4348—117th Congress (2021–2022): FDASLA Act of 2022." July 13, 2022. https://www.congress.gov/bill/117th-
congress/senate-bill/4348.

George G. Misko, Esq., is a partner in the Washington, D.C., office of Keller and Heckman LLP.

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

FOOD SAFETY INSIGHTS
By Bob Ferguson, President, Strategic Consulting Inc.
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Evolving Relationships Between

Food Processors and Regulatory
Agencies
Processors speak out about how they are coping with
regulatory demands now that FDA has resumed in-
person inspections
Image credit: MiguelMalo/E+ via Getty Images

This issue's Food Safety Insights column is a continuation of the survey that we first reported in our
August/September issue. That survey included over 450 food processors and food safety professionals in every
category in the U.S., Canada, and from around the world. In the August/September column, we discussed the pent-
up demand for projects and new initiatives that processors are hoping to return to, with some of the urgency and
disruptions from the COVID-19 pandemic becoming less acute. In this column, we continue to report on our
results, but these questions are related to how processors are coping with regulatory demands now that the U.S.
Food and Drug Administration (FDA) and other agencies have resumed their in-person inspections. We report on
industry's relationships with various agencies, but we give extra focus to the companies' relationship with FDA. Of
the 450 respondents in our survey, approximately 200 reported that they are FDA-regulated facilities.

We have been monitoring the relationship that food processors have with regulators—particularly with FDA—for a
number of years now. Our attention to this topic started with the implementation of FDA's Food Safety
Modernization Act (FSMA)—arguably the most impactful food safety regulatory change in recent memory—to
watch the evolution of FDA's enforcement posture, as well as inspection and sampling procedures related to this
new regulation. This evolution was somewhat disrupted by the COVID-19 pandemic over the past few years, but
now that FDA has resumed its regular, in-person inspections, we wanted to hear from processors whether they
have had an inspection in 2022a and, if so, whether FDA collected any samples. We also asked if processors still
agree that FDA "educates before it regulates."

FDA Resumes In-Person Inspections

Let's first add some background to this second issue regarding FDA's position that it will strive to "educate before it
regulates." From the beginning of the implementation of FSMA, FDA has indicated its plan to "educate before and
while it regulates." FDA has said that it was, and is, its intent to conduct interactive inspections working closely
with food processors that will emphasize education to help industry comply with FSMA and focus enforcement
actions on the food safety problems that pose the greatest threats to public health.

In 2017, ahead of the first FDA FSMA inspections, we asked processors if they accepted FDA's claim that the agency
will "educate before it regulates." At that time, it was safe to say that industry was skeptical, with our survey
showing that only 40 percent of the respondents agreed that this was likely. In 2019, after several years of FSMA
inspections, we asked this question again and found that the industry's attitude had changed, with 72 percent of
processors in our survey agreeing at that time that FDA was indeed educating first.

Now, in 2022, following FDA's post-COVID-19 resumption of in-person inspections, this acceptance of FDA's
position continues to be accepted by food processors (Figure 1), with 74 percent of processors in North America
and 79 percent of international companies in this survey still agreeing.

FIGURE 1. Do You Believe that FDA Educates Before it Regulates?

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With FDA resuming its in-person inspections, we also wanted to know how these inspections were progressing.
Approximately one-third (Figure 2) of FDA-registered facilities in our survey reported that they have had an FDA
inspection so far in 2022.a Interestingly, the rates reported by the processors in both North America and
internationally were similar.

FIGURE 2. Have You Had an FDA Inspection in 2022?

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Sample Collection

An issue of importance to many processors is the collection of environmental samples by FDA during inspections.
Not only can this regulatory sampling be an anxiety-producing test for the regulated company and its food safety
professionals, but any samples collected that are found to be positive for food pathogens also likely will be
analyzed using Whole Genome Sequencing (WGS). Those sequences will be added to the Agency's GenomeTrackr
database and may be found or referenced in future investigations of foodborne illnesses or outbreaks. For these
reasons, FDA sampling events always get the attention of in-plant food professionals.

As an indicator of what has been happening in 2022, only 11 percent (Figure 3) of those FDA-regulated facilities
in North Americab that have had an inspection in the first half of 2022 reported that FDA collected environmental
samples from their facility. For comparison, in previous surveys, closer to 30 percent of processors reported that
FDA had collected samples during its onsite inspection. It is reasonable to expect that this 11 percent figure is low,
and likely represents a post-COVID-19 "gearing up" of the agency's work in the first half of this year. We should
expect to see a higher frequency of sampling going forward.

FIGURE 3. If You Have Had an FDA Inspection in 2022, Did FDA Collect Environmental Samples?

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FSMA Implementation Challenges

We also revisited another question that we have asked in previous surveys: "What are your biggest concerns with
the implementation of FSMA?" For the North American companies, the issue reported most frequently (Figure 4)
involved understanding the specific requirements needed to comply with FSMA, especially those requirements
that would be raised during a regulatory inspection. This is a similar result to what we have seen in previous
surveys.

Several respondents reported that it is difficult to keep up with changes. One commented, "We are still waiting for
the final version of FDA's Intentional Adulteration guidance documents; yet, during our inspection, we were
expected to be in compliance." Another indicated, "It seems that there has been very limited updates on any
changes, and even if you are on the FDA listserve, you are never quite sure if you have all the most current
information."

Other respondents reported that they are doing what they can to keep up, with one commenting, "Training is
available, but it is costly, and different FDA inspectors interpret rules differently, making for extra work and
causing confusion." Another mentioned that they have been turning to other resources for help, saying, "We have
a good working relationship with our state inspectors, who are helping us prepare for our next FDA inspection."
FIGURE 4. What Have Been your Biggest Concerns with the Implementation of FSMA or Your Efforts to Comply with FSMA?

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The second most-reported issue was finding the staffing and resources, especially money, to get it all done. These
comments ranged from difficulties in securing enough qualified food safety specialists to work in their program to
having the resources to keep them trained on current requirements. To summarize the numerous comments on
this topic, many respondents indicated that they are trying to deal with far too many issues while working with
insufficient staff, they are stretched for time, and they have too few resources to procure the tools they need to
accomplish everything.

Interestingly, the most-reported issue for international companies was getting buy-in for the implementation of
changes needed for FSMA compliance. Many respondents mentioned having to motivate their company to make
the needed changes from their current program to one that is compliant with FSMA. Some indicated that they are
encountering general resistance to commit the resources needed for compliance. Others, however, mentioned
more technical compliance issues such as changing their Hazard Analysis and Critical Control Points (HAACP)
program to include Preventative Controls, or overcoming the thinking that Good Manufacturing Practices (GMP)
or Food Safety System Certification (FSSC) compliance can substitute for FSMA compliance.

Companies outside of the U.S. are more likely to need to comply with regional and national regulations other than
FSMA, and it seems that some management teams are rationalizing that compliance with those regulations or
certifications should be sufficient justification for the quality of their program. This creates a conflict with
management and roadblocks in the implementation of FSMA requirements, yet the food safety people understand
that as long as they will be exporting to the U.S., FSMA compliance is necessary.

An Ever-Evolving Relationship

It seems that the relationship between processors and regulators has improved, although there is still work to be
done. While there will always be limitations on resources and pressure to "do more with less," it is clear that food
safety departments are working hard to maintain their staffing and appropriate resources to address their day-to-
day responsibilities and also respond to new regulatory requirements—or, as the saying goes, "trying to change
the tires on the car while going 60 miles per hour." As these are important and relevant questions for anyone in
food safety, we will continue to ask these questions, monitor the progress, and report on what we find here in
Food Safety Insights.

Notes

a. As of the date of our survey in early June 2022.

b. A larger percentage of international facilities reported that FDA had collected samples during their inspection, but the sample size was small,
and too few of the overall number facilities responded to the question, further reducing the sample size and making it too small for the data to
be relevant; therefore, we are not reporting the figures here.

Bob Ferguson is President of Strategic Consulting Inc. and can be reached at bobferguson9806@gmail.com​ or on Twitter at @SCI_Ferguson.

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FOOD - S A FET Y . C OM OC T OBER / NOVEM BER 2 0 2 2

REGIONAL CULTURE
By Lone Jespersen, Ph.D., Principal, Cultivate; John David, Global Scientific Marketing Manager, 3M;
and Sophie Tongyu Wu, Ph.D., Senior Research Assistant at University of Central Lancashire

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Global Food Safety Culture: Latin

America
Latin American leans toward indirect, high-context
communication and relationship-based culture
Image credit: Sunan Wongsa-nga/iStock / Getty Images Plus via Getty Images

Panelists Michele Fontanot, Ph.D. (Professional Service Manager, 3M Latin America), Paola Lopez (Quality
Assurance Manager, Sigma), and Lone Jespersen, Ph.D. (Cultivate, Switzerland) identified three key characteristics
on the food safety culture in Latin America region: a culture of caring, empowerment, and authentic food safety
culture as a competitive advantage.

Culture of Caring

A deep sense of "culture of caring" prevails in Latin America. This relationship-based culture, with its relatively
indirect, high-context communication (Figure 1), signals the importance of trust-building at work. As one panelist
described, building relationships and coordinating teamwork are like dancing. Cultivating food safety culture is to
foster a sense of team, create innovative teamwork, nurture meaning and relevance about food safety in everyone,
and consequently transform food safety culture to a natural way of life. Since people's learning styles differ, it is
important to respect the differences and work on the similarities. As the webinar panelists noted, "A quality
system must have elements that encourage a sense of belonging."

FIGURE 1. Cultural Characteristics of Six Latin American Countries and the U.S.1

While a trusting food safety culture can be a competitive advantage, this relationship-centric culture could, on the
other hand, encumber opportunities for challenging food safety as a team. Therefore, ways to critically discuss
food safety can be integrated into work relationships.

The Latin American countries are also relatively flexible in time management. They lean toward "principle first,"
indicating the preference of learning about concepts and principles before adoption, unlike the U.S., one of their
biggest trading partners (Figure 1).1 

Indeed, it is important to understand the culture of one's customers in a globalized world. Given that regional
cultural characteristics play a role in developing food safety culture, keeping the cultural differences in mind can
help foster trust and relationships in working with global customers.

Importance of Empowerment

Empowerment and encouragement are fundamental in cultivating food safety culture in the Latin American
region. The organizational culture is meant to support everyone in the ownership of their role—via teaching them
the knowledge, developing their skills, giving them time to mature, and importantly, connecting the
responsibilities as a network. As a result, people understand how they fit together in the food safety system and in
the workflow; this sense of personal relevance, in turn, evokes pride in what they are doing.

Dr. Michele Fontanot recounted an anecdote at her previous employer, where, to help the frontline own the
process, she engaged the operations teams and supervisors in building their Hazard Analysis and Critical Control
Points (HACCP) plan. Traditionally, however, the food safety and quality (FSQ) team held exclusive ownership to
the HACCP plan. Although it took three years to revamp the system, the revised flow worked well, and the
frontline was able to take responsibility of their line and the products. Indeed, food safety is not framed around
punitive measure; its value is rooted in encouraging people to find ways to improve and giving power to make
them stronger.

Authentic Culture as a Competitive Advantage

While food safety is not a competitive advantage, food safety culture is. A 2014 study2 found that 54 percent fewer
mistakes were made in the business of a mature culture, leading to lower cost of quality, including prevention cost
(e.g., process equipment preventative maintenance and employee training), appraisal cost (e.g., food safety and
quality audits), internal failure cost (e.g., waste and rework of products), and external failure cost (e.g., product
withdrawal and recall).

Two motivators are found in food safety culture in the Latin American region: authenticity and competitive
advantage. Giving authenticity to food safety culture starts from the leaders, who set this vision in business
expectations (Figure 2). As most FSQ decisions are made by the FSQ teams, it is necessary to plant food safety in
the strategic initiative in the business leadership. Behaviors and systems should align with the organizational
culture and company's food safety message, and leaders should promote food safety meanings on a daily basis
(Figure 3). A FIRST model (Fundamentals, Infrastructure, Risk analysis, Scorecard, and Training) helps identify
and evaluate quality culture, as well as capture mindset, skills, and infrastructure.

FIGURE 2. Principles of Authentic Quality Culture

FIGURE 3. Align Behaviors with Quality Culture

Being a crucial player in the global food chain inspires Latin American countries to pursue positive food safety
culture as a competitive advantage to help fulfil their duty. As the industry grows with the market, there is a rising
need to standardize food safety culture language among Latin American countries—i.e., what food safety culture
means, and what is expected from each person. The lack of a common language renders double standards facing
local and global markets. Recalling "authentic quality culture" (Figure 2), there is a need to create an integrated
management system, to maximize productivity along with food safety and quality. It is not only about training and
audits, but also "teamwork like a choreographed dance." This emphasizes shared responsibility across and
throughout the organization so that everyone has a role in food safety, owns the process, and aligns with the
company's expectations—or tengo, sé, puedo ("I have, I know, I can").

References

1. Meyer, Erin. The Culture Map: Breaking Through the Invisible Boundaries of Global Business. New York, New York: Public Affairs (2014).

2. Srinivasan, Ashwin and Bryan Kurey. "Creating a Culture of Quality." Harvard Business Review. April 2014. https://hbr.org/2014/04/creating-a-
culture-of-quality.

Lone Jespersen, Ph.D., is a principal at Cultivate, an organization dedicated to helping food manufacturers globally make safe, great-tasting food through
cultural effectiveness. She has significant experience with food manufacturing, having previously spent 11 years with Maple Leaf Foods. Dr. Jespersen is also
a member of the Food Safety Magazine Editorial Advisory Board.

John David is Global Scientific Marketing Manager at 3M. He holds a master's degree in molecular biology and genetics and a bachelor's degree in
biological sciences, both from the University of Delaware.

Sophie Tongyu Wu, Ph.D., is a Senior Research Assistant at University of Central Lancashire and a member of Cultivate SA. She leads a food safety culture
improvement project at ten UK food manufacturing companies to collect organization-wide feedback for targeted action. Dr. Wu holds a Ph.D. in food
science and technology from Purdue University and a bachelor's degree in biology from the University of Wisconsin–Madison.

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By Dhruv Kishore Bole, Consultant
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How Restaurant Operators can

Handle Food Poisoning
Allegations
Restaurants must handle foodborne illness claims
professionally, and a framework for investigating
consumer food poisoning allegations must be in place
Photo credit: jacoblund/iStock / Getty Images Plus via Getty Images

Foodborne illnesses cause a considerable number of hospitalizations and deaths around the world annually, and
the role of restaurants in food poisoning incidents has been widely publicized. Every restaurant owner wants to
avoid foodborne illness incidents and accusations, since a single lawsuit stemming from a food poisoning incident
can have serious consequences for the restaurant's business, including poor brand image, high legal costs, and
reduced customer loyalty. This article examines how restaurant operators can handle food poisoning allegations
from customers. Before discussing these recommendations, let us first examine the cause of some common
foodborne illnesses.

When a customer claims to have become ill after eating at a restaurant, it may be a case of foodborne illness. A
foodborne illness outbreak can be said to occur when two or more customers become ill after dining at the same
restaurant. Eating food contaminated with harmful pathogens is one of the primary causes of food poisoning. The
majority of foodborne illnesses and outbreaks are caused by pathogens such as Escherichia coli, Campylobacter,
Listeria monocytogenes, Salmonella, Clostridium perfringens, and Staphylococcus aureus, as well as viruses such as
norovirus and astrovirus. Meat, seafood, poultry, eggs, unpasteurized dairy products, and some vegetables are
among the foods often associated with food poisoning.

Some of the reasons food contamination occurs in restaurants are cross-contamination, poor personal hygiene of
staff, poor receiving controls, improper storage, and during the preparation and service of food. Vomiting, nausea,
stomach cramps, and diarrhea are the most common symptoms of most foodborne illnesses, and they often
manifest two to six hours after consuming contaminated food. Some pathogens cause illnesses that may not arise
until several days after exposure. Everyone is susceptible to food poisoning, although particular populations such
as the elderly, pregnant women, children under the age of five, and people with impaired immune systems are
more vulnerable. The vast majority of patients recover in a few days without medical intervention, but some suffer
from severe symptoms that necessitate hospitalization. In the worst-case scenario, food poisoning can cause
organ damage and death. The severity of the food poisoning is dictated by the amount of contaminated food
consumed, the type of pathogen, and the individual's age and overall health status.

Addressing Foodborne Illness Allegations

Restaurants must handle foodborne illness claims professionally, and a framework for investigating consumer
food poisoning allegations must be in place. It is vital that restaurant top management choose someone capable of
competently handling customer claims of food poisoning and incidents of foodborne illness outbreaks. The
responsibility must be assigned either to a restaurant manager or an executive chef. Designated individuals at the
restaurant may also be asked to handle media coverage resulting from such incidents.

Restaurant managers are often the first choice for this role, since the processes involved in food preparation and
service are scrutinized when food poisoning events are investigated. Another reason is that restaurant managers
are frequently the first point of contact for customers. It is crucial to emphasize that if the restaurant manager is
entrusted with handling food poisoning complaints, senior management must be kept up to date on every
complaint that a customer raises with the restaurant. Senior management support is also essential when dealing
with such concerns because these instances include calling the local public health department, engaging an
attorney, meeting with vendors, and communicating with insurance companies. Senior management must
nominate a management representative to provide the necessary assistance.

Customers also want to be heard and have their concerns addressed. It goes without saying that effectively
handling food poisoning customer complaints can help avoid negative brand image and personal liability claims. It
also contributes to the restaurant's professional image. Restaurant owners should follow the procedure outlined
below to effectively handle allegations of food poisoning.

Show Empathy Without Accepting Responsibility

Customers typically report food poisoning by calling the restaurant directly, but some may also report on the
aggregator's website or social media pages. Whether a consumer phones the restaurant directly or posts a
complaint on social media, it is vital to be sympathetic and empathic with the guest. Assure the guest that the
complaint is being taken seriously and that it will be discussed with the team, investigated, and the result of the
investigation communicated to the guest. In addition, notify the guest if no other customers have complained of
food poisoning.

Remember to be empathetic and caring, but refrain from accepting responsibility for the food poisoning incident.
This recommendation is made for two reasons. First, if the restaurant takes responsibility, it can be used as
evidence in court if the customer files a personal injury lawsuit. Another plausible reason is that the restaurant
has not yet investigated the foodborne illness incident, and furthermore, customers may have eaten contaminated
food somewhere other than the restaurant.

Another thing to remember when dealing with food poisoning allegations is to refrain from passing judgment on
the incident. Never assume or tell a customer that they acquired food poisoning from somewhere else, rather than
from your restaurant's food. Furthermore, never give medical advice or agree to pay for the guest's medical
treatment. In some cases, customers threaten to report the incident to the Health Department or file a personal
injury lawsuit; in these instances, avoid becoming aggressive with the guest or engaging in an argument.     

The next step is to gather information from the customer. The following information must be collected:

Customer’s name and contact details.

When did the customer dine at the restaurant, and what dish was ordered? Make sure to ask if there were
any modifications made to the order per the customer's request, as this could indicate an ingredient
substitution or addition that would not normally be included in that dish.

Ask if the customer dined alone or in a group. If they dined in a group, did any of the other members
consume the same food and experience similar symptoms?

Did the customer take leftovers from the meal home with them? If yes, how was the food handled before
it arrived home, and how it was handled after it arrived home until it was consumed?

What symptoms is the customer experiencing?

When did the customer begin experiencing symptoms?

If symptoms have already abated, how long did the symptoms last?

What foods did they consume before and after dining at the restaurant?

Did the customer seek medical advice? Request a copy of the medical report, if they have seen a doctor. If
they have not sought medical advice for their symptoms, then encourage them to do so.

Ask if they have notified the local environmental health department.

Request that the customer share a copy of their bill. The customer’s dining details must be verified.

Inquire if the customer has arranged a laboratory analysis on any food leftovers. If they have, request a
copy of the report.

"Public health officers may seek a copy of the

customer complaint form during an investigation.
It can also be used as evidence documentation in
food poisoning lawsuits."
Document the Foodborne Illness Complaint

Documenting a food poisoning allegation is the first step in investigating it. Fill out a food poisoning complaint
form or an incident report with all of the essential details, after the customer's dining information has been
verified. Public health officers may seek a copy of the complaint form during an investigation. It can also be used
as evidence documentation in food poisoning lawsuits. Every restaurant must have a foodborne illness complaint
form readily available.

Inform the Local Health Department

Restaurant owners are recommended to notify the local health authorities of the food poisoning incident and
inform them that the food poisoning accusation has been documented, the restaurant staff has been informed, and
an investigation is underway. In some countries, restaurant owners are required to notify local health authorities
when a food poisoning incident occurs. This illustrates that the customer's complaint is taken seriously and
highlights the restaurant's dedication to rectifying the incident. Moreover, the incident, according to authorities,
must be reported by the restaurant business rather than by the guest.

In times of crisis, the public health department can be the restaurant's most valuable ally. In cases of foodborne
illness outbreaks, a doctor at the hospital may alert the local public health department and share customer
information with them. Stool samples are often tested to identify the pathogen responsible for the food poisoning.
If foodborne pathogens are discovered in victims' stool, then the doctor may notify the public health department
to determine whether the food poisoning case is linked to a foodborne illness outbreak.

When a public health officer inspects a restaurant following an incident of foodborne illness, the restaurant's food
handling processes are reviewed, employees are interviewed, and food samples are collected for testing. The food
poisoning complaint form should be given to the investigating officer when a public health official requests it.
Once the public health department's investigation is concluded, it is prudent to request the inspection report and
seek the health department's advice. This will aid in the discovery and troubleshooting of problems, as well as the
establishment of corrective actions.

Based on the investigation findings, the public health inspector may request that the restaurant close voluntarily.
Voluntary closures are not enforced, but following them can help prevent the restaurant's reputation from further
erosion. The environmental health team will later re-inspect the restaurant to determine whether or not the
problems that led to the foodborne illness outbreak have been corrected. Restaurants are permitted to reopen only
after the environmental health officer is satisfied with the corrective actions implemented.

Investigate the Incident

Restaurant managers must analyze the procedures involved in food preparation and service to uncover the
likelihood and source of the food contamination. This includes the following:

Check to ensure that the food item was adequately inspected and received in compliance with the
receiving controls. Notify the supplier if food items are received in line with receiving controls, but
contamination is suspected at the supplier's end—for example, food poisoning contracted after
consuming raw oysters that are correctly received and prepared.

Inspect temperature logs for refrigerators and walk-in coolers to check that ingredients were stored at the
proper temperature. This helps eliminate the possibility of contamination during storage. When specific
ingredients or food items are in doubt, request that the chef not use them. Such items must be kept
frozen and sent to a laboratory for testing. These efforts will help prevent future foodborne illness
outbreaks.

Check with the chef to ensure that the meal was prepared in accordance with food safety standards and
cooked to the minimum safe temperature. Were the ingredients fresh and handled properly, and was the
equipment used to cook the food sanitary at the time of use? Determine who prepared the food and verify
their health status.

Check whether food was contaminated at any point during the service. Was the food handled safely
throughout the service? For example, if a buffet was served, was the food kept at the proper temperature?
Were any of the service members ill or did they exhibit any symptoms of illness? When handling food,
did the service employees maintain personal hygiene and sanitary service procedures?

Determine whether the same food was served to other customers.

After the investigation is concluded, the restaurant manager must write an investigation report outlining the
findings (whether or not the restaurant's food was deemed to be responsible for the food poisoning) and submit it
to top management. A copy of the food sample report, customer invoice, kitchen order ticket copy, and food
poisoning complaint form must be attached to the investigation report. The restaurant must keep a copy of the
report on file. During an inspection, the public health officer may request to see a copy of the investigation report.

Follow Up With the Customer

Inform the guest if the investigation reveals that the restaurant food was not to blame for the food poisoning. To
avoid similar incidents in the future, it is always preferable to revamp the restaurant's food safety practices. If it is
determined that restaurant food was to blame for food poisoning, then notify the restaurant's attorney. It is also
necessary to notify the restaurant's insurance company of the incident. When a lawsuit is filed, an attorney can
step in and handle the claim. Remember not to contact the customer after a lawsuit is filed, as this may be
interpreted as witness tampering.

Food poisoning lawsuits are often categorized as product liability lawsuits, which is a type of personal injury
claim. Many incidents of food poisoning are unreported. This is due to the fact that some people are unaware of
foodborne illness in general, and many people experience mild symptoms and recover without medical
intervention. However, food poisoning complaints still require prompt and thorough investigation. They are tough
to prove, however, since it is difficult to pinpoint the source of the contamination, as well as the cause of the
illness. Some people may suffer symptoms days after eating contaminated food, making the determination of the
source of contamination challenging. The sooner symptoms appear, the easier it is for medical professionals to
determine the cause of the food poisoning.

The evidence available to the claim against the negligent restaurant determines the success of the food poisoning
lawsuit. During these types of lawsuits, the restaurant's history of product liability lawsuits, health code breaches,
food safety procedures, employee personal hygiene, contractual vendors, and facility cleanliness will be examined.
Medical proof of food poisoning, as well as its causes, will also be considered. In cases when public health
authorities can prove that contaminated restaurant food was to blame for the foodborne illness outbreak, the
foodservice establishment's negligence can be easily established. Another important consideration in food
poisoning claims is the time restriction. It is imperative to note that different jurisdictions have different time
limits for filing a food poisoning lawsuit.

The law allows the plaintiff (customer) to seek compensation for actual harm experienced, such as medical costs
and hospitalization bills, lost income, and subjective losses such as emotional distress and pain and suffering. The
law may require the negligent restaurant to pay compensation for disability or organ damage. In the event that a
customer dies as a result of food poisoning, surviving family members may file a wrongful death lawsuit to seek
compensation. In circumstances where a foreign object—such as metal, plastic, or glass—in food causes consumer
injury, such as throat or stomach injury, the law requires the negligent restaurant to compensate the customer.

Incidents of food poisoning are unanticipated and can be extremely damaging to restaurants; however, they are
also largely avoidable. Restaurant operators must have a food safety management system in place to strengthen
food handling processes. It is also critical that senior leadership build a food safety culture in the restaurant, train
and encourage employees to practice safe food handling and serving practices on a constant basis, and appoint a
skilled and experienced restaurant manager to monitor restaurant operations. Sourcing food items from reputable
and licensed vendors only after successful verification is conducted is equally important. Also, an insurance policy
should be chosen that covers the costs of lawsuits originating from food poisoning incidents, such as restaurant
contamination insurance.

It is important to remember that consistency is the key to ensuring food safety, and it is always better to be
proactive than reactive. Restaurant owners have a social responsibility to protect their customers' health by being
proactive in their management and enforcement of food safety practices.

Dhruv Kishore Bole is a hospitality and food safety specialist with qualifications in hotel management, food safety, and quality management systems. He
has extensive experience spanning more than 12 years in operational and training roles. His expertise centers on hospitality operation, food and beverage
services, and food safety. He is certified by the Food Safety and Standards Authority of India in food safety competencies. He is currently offering services in
the capacity of Faculty, Food & Beverage service at the State Institute of Hotel Management in Siddhpur, India.

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'All-in-One' Inspection Solutions

Antares Vision Group, +39 030-728-3500   

Antares Vision Group (AVG) recently introduced a new series of inspection

machines that offer comprehensive, customizable packaging inspections for food
and beverage applications. T he company's All-in-One equipment portfolio
incorporates multiple inspection controls into single machines, maximizing
production space and labor efficiencies while also meeting manufacturers' quality
control needs. T he All-in-One models enable food and beverage companies to:

Check for the presence of micro-holes in packag ing : All-in-One models can incorporate an in-line system to detect micro-
holes. T his functionality is applicable to both trays and flow packs, and does not require changing line speed or composing
gas for product conservation. Based on IR spectroscopy or gas sensors, the system selectively, quickly, and accurately
identifies the presence of target molecules exiting the package, indicating a micro-hole. For precision micro-hole detection, it
is possible to use CO2 as the target molecule for products in modified atmosphere packaging, alcohol for the bakery sector,
and common flavorings for certain other products.
Check for the presence of foreig n bodies: X-rays are used to detect fragments of glass, bone, metal, plastic, or stones that
may have accidentally ended up in the product during the production process, or as raw materials leftovers.
Check the product weig ht: Weight checks help avoid food waste, monitor and optimize production line efficiency, and
comply with North American and EU regulations concerning product weight inspection.

Check product seals: All-in-One machines can utilize hyperspectral technology to detect the presence of food in the seals of
transparent, colored, and opaque packaging.

Check labels and codes: T he system prevents products with labeling errors (such as incorrect expiration date or lot code) or
other incorrect information from reaching the market.
Other advantages of the All-in-One series include reduced machine dimensions (with a similar footprint as most standard
checkweighers), a single user interface overseeing all inspection parameters, differentiated waste and automatic recipe settings, and
reduced energy consumption. In addition, each machine in AVG's All-in-One series can be integrated into the company's Digital Factory
software platform, which seamlessly connects all solutions to optimize production and monitor efficiency.

antaresvision.com SCROLL
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Foreign Material Alert with AI

Key Technology, +1 509-529-2161 

Key T echnology recently introduced the new artificial

intelligence (AI)-driven FM Alert software for its digital sorting
systems. T he AI tool captures and saves digital images of
critical foreign material (FM) contaminants that the sorter
detects and rejects from the product stream. Data outputs
from the software can be utilized to immediately alert
operators and send signals to a downstream device. As Key's
sorters find and remove FM and a variety of user-specified
defects, users can program FM Alert to act on specific types of
critical FM such as glass, plastic, rubber, and wood.
Additionally, FM Alert data outputs can be utilized to trigger a
gate or diverter downstream of the sorter to segregate at-
risk product, allowing an operator to confirm that the critical
FM was physically removed from the product stream.

Complementing FM Alert, Key's Discovery software can be used to gain additional insight into the frequency and type of FM
events. Discovery allows processors to use their Key sorters to collect, analyze, and share data about the sorting process and the
objects that flow through the sorter. Information about the sorter's findings allows processors to recognize trends and
correlations, enabling processors to eliminate root causes. T he documentation supports quality assurance for the processor, as
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key.net

Allergen Testing App Non-BPA Coating for Aluminum

Hygiena, 1-888-494-4362 
Beverage Cans
Although allergen testing has long been incorporated into PPG has announced its new product, PPG Innovel® PRO, an
standard operating procedures, allergen test results were enhanced internal spray coating that uses no bisphenol-A
traditionally reported in isolation, rather than as a component (BPA) or bisphenol starting substances. PPG Innovel PRO
of a holistic cleaning verification and quality release process. provides robust application properties for recyclable
T herefore, operators have been unable to easily incorporate aluminum beverage cans. PPG Innovel PRO is a next-
allergen detection into their businesses' larger environmental generation, high-performance acrylic coating that expands on
monitoring database, hindering the ability to monitor process PPG Innovel's decade-long tenure as the market's most widely
and cleaning control efficacy. used non-BPA internal beverage spray coatings. T he coating
features a lower migration profile than standard epoxy and
In light of these issues, Hygiena has launched its new EnSURE
epoxy-mimic coatings, and all PPG Innovel internal spray
T ouch Allergen App, which harmonizes the company's AT P
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cleaning and environmental monitoring system, EnSURE
material health certification from the Cradle-to-Cradle
T ouch, with its line of allergen tests, including: AlerT ox® ,
Products Innovation Institute.    
AllerFlow, and GlutenT ox®  Pro. T he Allergen App integrates
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allergen test results into overarching environmental test
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Additionally, Hygiena's SureT rend®  Cloud data management
system allows for customized report consolidation, trend
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hyg iena.com

Clean-Label Solution for Preventing TAB

Spoilage
Gat Foods, +972 46-368-801
Resorcix Ltd., +972 02-5025-229 

Gat Foods, part of International Beer Breweries, Ltd. (IBBL), and Israeli startup
Resorcix Ltd., have introduced FLAVORWAT CH, a natural, botanical ingredient
with the ability to prevent T hermophillic Acidophilic Bacteria (T AB) spoilage in
clear, fruit-based beverages. FLAVORWAT CH can maintain the flavor of a
beverage throughout its shelf life while mitigating T AB spoilage.
T AB refers to a group of nonpathogenic microbes belonging to the Alicyclobacillus family and is common in still, ready-to-drink
(RT D), non-alcoholic beverages. T AB is able to withstand pasteurization and can multiply rapidly in acidic environments. T AB
originates from certain ingredients that are frequently used in beverage preparation, such as sugar, pectin, water, and fruit
concentrate. T AB will multiply shortly following the bottling process, especially in warm weather. Good manufacturing practices
can reduce T AB but cannot eliminate it entirely, necessitating periodic batch testing and isolation, which is costly, time-consuming,
and not 100 percent effective. Indications of T AB spoilage in beverages include a hazy appearance, a clove-like smell, and a
medicinal taste. Although nonpathogenic, the unpleasant results of T AB contamination typically lead to a large volume of
customer complaints and can ultimately trigger a costly recall and damaged reputation.
FLAVORWAT CH contains natural compounds with a proven bacteriolytic effect that disintegrate T AB cells in the germination
phase. T he product also prevents the bacteria from producing unpleasantly flavored and scented metabolites. FLAVORWAT CH is
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flavoring by the U.S. Food and Drug Administration (FDA), the European Food Safety Authority (EFSA), the Japan External T rade
Organization (JET RO), and the Israeli Ministry of Health. It is suitable for a variety of still, clear, RT D beverages, such as fruit
beverages, fruit-infused water, and iced teas. T he product is easy to use, cost effective, and can be added to beverage bases or
syrups in the preparation phase or directly to the beverage tank before pasteurization.

www.gatfoods.com

www.resorcix.com

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