LISTERIA

MONOCYTOGENES:
GUIDANCE ON ENVIRONMENTAL MONITORING AND
CORRECTIVE ACTIONS IN AT-RISK FOODS

GROCERY MANUFACTURERS ASSOCIATION

Guidance for Industry
Second Edition • July 2018

Listeria monocytogenes Guidance on Environmental Monitoring

and Corrective Actions in At-risk Foods

ACKNOWLEDGEMENTS
The Grocery Manufacturers Association (GMA) gratefully acknowledges the contributions of everyone
involved in the update of this document:

Tim Adams Sally Crowley Scott Li

Kellogg Company Cargill Rich Products Corporation
Deann Akins-Lewenthal Virginia Deibel Joseph Meyer
ConAgra Covance Laboratories The Kraft Heinz Company
Elise Binder Phil Elliott Molly Mills
The Hershey Company Kellogg Company PepsiCo

DeAnn Benesh Judy Fraser-Heaps Ruth Petran

3M Company Land O’Lakes Ecolab
Dennie Brown Timothy Freier Nancy Rogers Bontempo
Pinnacle Foods Mérieux NutriSciences Mondelēz International

Dominic Caravetta Scott Hood Warren Stone

Unilever. General Mills GMA

Tom Cherven Ai Kataoka

Bumble Bee Seafoods GMA

Fred Cook Jeff Kuehm

Post Consumer Brands PepsiCo

The original document was prepared by Richard Brouillette (Commercial Food Sanitation, formerly
Mondelez International), David Aggen (retired, formerly Lakeside Foods), Brian Borchert (Sara Lee
Corporation), Kurt Buckman (Pinnacle Foods Group LLC), Mark Domanico (retired, formerly Kellogg
Company), Judy Fraser-Heaps (Land O’Lakes), Timothy Freier (Cargill), Melinda Hayman (GMA),
Timothy Jackson (Driscoll’s Inc. formerly Nestlé NA), Ai Kataoka (GMA), Joseph Meyer (Covance
Laboratories, formerly Kellogg Company), Emily Shoaf (WhiteWave Foods, formerly GMA), and Warren
Stone (GMA).

The Grocery Manufacturers Association has worked to ensure that all information in this guidance is
accurate as of the time of publication and consistent with standards of good practice. As laws and
practices advance, however, standards may change. For this reason, it is recommended that readers
evaluate the applicability of any recommendations in light of particular situations and changing laws and
standards.

Copyright © July 2018 Grocery Manufacturers Association. All rights reserved. No part of this work covered by the
copyright hereon may be reproduced or used in any form or by any means—graphic, electronic, or mechanical,
including photocopying, recording, taping, or information storage and retrieval systems—without the express
written permission of the publisher. For permission requests, please email [email protected], or contact
Publications by telephone at: 1-800-355-0983.
TABLE OF CONTENTS
INTRODUCTION ....................................................................................................................... 4
Listeria monocytogenes ......................................................................................................... 4
L. monocytogenes in Ready to Eat (RTE) foods ..................................................................... 4
Objectives .............................................................................................................................. 5
Environmental Monitoring Program as a Verification Tool ...................................................... 5
FDA Food Safety Modernization Act and Environmental Monitoring....................................... 6

COMPONENTS OF A LISTERIA ENVIRONMENTAL MONITORING PROGRAM ..................... 8

Management Commitment ..................................................................................................... 8
Risk Consideration: Is a LEMP Recommended? .................................................................... 9
Risk Consideration: What Affects the Stringency of the LEMP? ............................................10
Monitoring for Listeria spp. ....................................................................................................10
Designing the Routine Monitoring Program ...........................................................................11
Sampling Procedures and General Guidance .......................................................................14
Sample Handling ...................................................................................................................15
Testing Methods....................................................................................................................15
Evaluation of Results ............................................................................................................16

INVESTIGATION AND CORRECTIVE ACTIONS .....................................................................16

Investigations ........................................................................................................................16
Response to an Initial Listeria spp. Finding (Zones 1, 2 and 3): ............................................18
Additional Actions for a Single Listeria spp. Finding in Zone 2...............................................19
Response to Reoccurring Positives (all Zones) .....................................................................21
Response to a Reoccurring Positive in Zone 3 ......................................................................21
Additional Actions for a Reoccurring Positive in Zone 2.........................................................22
Additional Actions for a Reoccurring Positive in Zone 1.........................................................22
Documentation ......................................................................................................................24

SPECIAL CIRCUMSTANCES ...................................................................................................31

Roof and Water Leaks in Exposed RTE Product Areas .........................................................32
Plant Construction or Equipment Installation .........................................................................32
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 Drainage Backups .................................................................................................................32
Other Operational Issues ......................................................................................................33
Recommended Practices ......................................................................................................33

VERIFICATION OF A LISTERIA ENVIRONMENTAL MONITORING PROGRAM ....................34

Environmental Monitoring Program Validation .......................................................................34
Environmental Monitoring Program Verification .....................................................................34

CONCLUSION AND SUMMARY...............................................................................................36

REFERENCES .........................................................................................................................37

APPENDIX: SANITARY DESIGN OF EQUIPMENT AND FACILITIES ........................................ i

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INTRODUCTION

Listeria monocytogenes

Listeria monocytogenes is a bacterial pathogen that is widely distributed in nature. L.

monocytogenes is pyschrotrophic1 and can tolerate high salt as well as a wide pH range. The
organism has been isolated from many raw agricultural products, raw meat and poultry products,
raw milk, and raw aquaculture products. L. monocytogenes has been associated with a number
of foodborne outbreaks in a variety of refrigerated food products, such as ready-to-eat (RTE)
meat, dairy products, processed vegetables as well as fish and seafood (1, 2, 3).

L. monocytogenes in Ready to Eat (RTE) foods

The presence of L. monocytogenes in RTE products is generally known to occur because; 1)

there is no lethality step or an insufficient lethality step, so that incoming materials do not receive
a process sufficient to eliminate Listeria on outgoing products (e.g., fresh or fresh cut fruit and
vegetables); 2) products are intended to undergo a listericidal treatment but are processed
incorrectly (e.g., an insufficient thermal process); or 3) the product has received a listericidal
treatment but has been contaminated or recontaminated from the processing environment. This
guidance will focus on the latter point for refrigerated RTE foods that can support the growth of L.
monocytogenes or have history of listeriosis; for clarity, the term “at-risk foods” will be used
throughout this document to describe these foods.

A number of the earliest listeriosis outbreaks in the US (late 1990s, early 2000s) were associated
with frankfurters, deli meats and other RTE meat products (1). A 2003 risk assessment conducted
by the US Food and Drug Administration (FDA) and US Department of Agriculture Food Safety
Inspection Service (USDA FSIS) identified deli meats as the food category most often associated
with listeriosis (as compared to other RTE foods such as soft cheeses, and smoked seafood) (3).
Due to the early association of listeriosis with RTE meat, the US meat industry was among the
first to implement an industry wide program to address the presence of Listeria spp. in the
processing environment and on product contact surfaces (PCS, also called food contact surface)
as a verification tool to ensure that control programs (e.g., supplier control, zoning, and cleaning
and sanitation) were effective in preventing potential cross-contamination of finished products.
Through collaborative efforts between food companies, industry associations, and regulatory
agencies, industry was able to aggressively pursue a “seek and destroy” approach to identify
possible harborage site(s) of the organism (4). Recent data published by the Centers for Disease
Control and Prevention (CDC) (1) shows that there has been only one outbreak involving L.
monocytogenes contamination of RTE meat (associated with hogs’ head cheese, 2010) since this
approach has been implemented. Although many factors have contributed to this outcome, such

1 bacteria that are capable of growth at low temperatures, including refrigeration temperatures.

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as formulating products to prevent the growth of L. monocytogenes, part of this success is
attributed to the allowance for taking corrective actions without holding/implicating/recalling
product in reaction to an isolated occurrence of positive 2 Listeria spp. on PCS.

To minimize listeriosis associated with at-risk foods, food manufacturers should consider
processes and/or formulations designed to prevent growth of L. monocytogenes in the finished
product. This could be accomplished by several techniques such as frozen distribution, post-
packaging treatment, the addition of antimicrobials, etc.

Objectives

The intent of this guidance document is to provide information to food manufacturers producing
at-risk foods in facilities where L. monocytogenes is a hazard requiring control measures to
prevent food from becoming adulterated. The document provides guidance on designing a
Listeria Environmental Monitoring Program (LEMP), which will in turn verify the efficacy of the
relevant prerequisite programs (such as sanitation, employee practices and sanitary design,
which is discussed in an appendix to the current document). The guidance will discuss the need
to conduct investigative sampling and root cause analysis when a potential harborage is identified,
including when and how to escalate LEMP activities. Using this “seek and destroy” approach
over time with appropriate data analysis and corrective actions will help to reduce the likelihood
of product contamination with L. monocytogenes and thus reduce the overall risk to public health.

Environmental Monitoring Program as a Verification Tool

Microbiological testing serves as a verification activity rather than a control measure, therefore
the LEMP is not a control program. The program should be designed to verify that other control
programs, such as facility and equipment sanitation, facility (hygienic) zoning, equipment design,
personnel practices, and traffic controls are effective in preventing post-process contamination.
A well-executed LEMP is a more preemptive and effective use of microbiological testing resources
than ingredient or finished product testing. This is because contamination of a product is often
sporadic and at low levels, whereas environmental niches may be expected to have higher levels
that are more readily detectable (5)

A LEMP is a “seek-and-destroy” program; the aim is to find, eliminate, and prevent establishment
of Listeria growth niches 3(6). The LEMP should focus on the detection of Listeria spp. rather

2Either a presumptive or confirmed test result that is indicative for the target organism (in this case
Listeria spp. or Listeria monocytogenes), as a result of either rapid or traditional test.
3A location that supports microbiological growth and is protected from the sanitation process;
characterized by high microbial counts after cleaning and sanitation (4).

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than L. monocytogenes. Targeting this group of broader indicator organisms 4 leads to more
robust verification of environmental conditions, and more rapid identification of niche and
harborage sites 5 that contain the pathogen or its indicator (4). If Listeria spp. is detected,
appropriate investigation and implementation of corrective actions can occur in order to prevent
potential contamination of the product by L. monocytogenes. This ultimately leads to greater
protection of the public health.

A successful LEMP is one that rewards aggressive investigation and does not penalize
finding Listeria spp. These positive results are viewed as an opportunity to strengthen and
improve manufacturing programs. Finally, a LEMP may not be appropriate for all production
facilities. The decision to incorporate a LEMP should be based upon a thorough risk evaluation
as discussed later in this guidance document. These principles can be used in other general
environmental monitoring programs (EMP), to support the overall food safety of post-lethality
exposed products.

FDA Food Safety Modernization Act and Environmental Monitoring

FDA’s Food Safety Modernization Act (FSMA) has been called the most sweeping reform of US
food safety laws in more than 70 years, since the Federal Food Drug and Cosmetic Act was
revised in 1938. FSMA was originally signed into law by President Obama on January 4, 2011,
and in the years since, FDA has developed seven final rules designed to enhance the safety of
the US food supply. FSMA shifted the FDA regulatory emphasis to ensuring food safety through
prevention of adulteration rather than simply reacting to the problem after it occurred. Compliance
dates for the various portions of the seven FSMA rules can be found at FDA’s website (7).

Subpart C of FSMA’s Current Good Current Good Manufacturing Practice and Hazard Analysis
and Risk-Based Preventive Controls for Human Food (PCHF), 21 CFR Part 117 (8), contains
requirements that facilities not eligible for an exemption (see 117.5) establish written food safety
plans (FSPs) including a detailed hazard analysis (Parts 117.126 and 130). The facility must
establish and implement risk-based preventive controls for any hazards determined to require a
preventive control for food safety. Monitoring, corrective actions, and verification procedures are
required for these control measures.

The hazard evaluation required by 117.130(c)(2)(ii) must include an evaluation of environmental

pathogens whenever a RTE food is exposed to the environment prior to packaging and the
packaged food does not receive a treatment or otherwise include a control measure (such as a

4An indicator organism is an organism whose presence indicates a state or condition (that could
contribute to the presence of a pathogen, whereas an index organism is an organism whose cell numbers
or frequency correlate with the cell numbers or frequency of another microorganism of concern. These
organisms are typically not pathogenic.
5 A growth niche that contains the pathogen or its indicator (4).

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formulation lethal to the pathogen) that would significantly minimize the presence of the pathogen.
Additionally, 117.165(a)(3) includes a requirement for “Environmental monitoring, for an
environmental pathogen or for an appropriate indicator organism, if contamination of a ready-to-
eat food with an environmental pathogen is a hazard requiring a preventive control, by collecting
and testing environmental samples…” 117.165(b)(2)(i – vii) requires that procedures for such
testing must:

 Be scientifically valid;
 Identify the test microorganism(s) or other analyte(s);
 Specify the procedures for identifying samples, including their relationship to specific lots
of product;
 Include the procedures for sampling, including the number of samples and the sampling
frequency;
 Identify the test(s) conducted, including the analytical method(s) used;
 Identify the laboratory conducting the testing; and
 Include the corrective action procedures required by § 117.150(a)(1).
While a LEMP procedure doesn’t include routine product testing, GMA recommends that
environmental testing procedures follow these same recommendations as appropriate.

In the preamble to the original proposed PCHF rule from January 2013, FDA indicated, “FDA’s
current thinking is that Listeria spp. is an appropriate indicator organism for L. monocytogenes,
because tests for Listeria spp. will detect multiple species of Listeria, including L. monocytogenes,
and because the available information supports a conclusion that modern sanitation programs,
which incorporate environmental monitoring for Listeria spp., have public health benefits” (Fed
Reg 78 page 3816) (9).

PCHF requires records be kept of all appropriate environmental monitoring activities including
corrective actions. These records must be made available to FDA upon verbal request for review
and copying.

In early 2017, FDA published draft guidance for the industry, “Control of Listeria monocytogenes
in Ready-to-Eat-Foods (0).” The draft guidance discusses control measures for L.
monocytogenes in food facilities that process all RTE foods, including environmental monitoring
programs as a verification practice. In the guidance, FDA encourages the industry to take a “seek
and destroy” approach for environmental monitoring programs. Furthermore, the draft guidance
encourages testing food contact surfaces for Listeria spp. and allows a company to continue
production without holding final products when detecting Listeria spp., as the first time. As
discussed earlier, this approach has received success in meat and poultry operations under FSIS
jurisdiction and when aligned to this guideline.

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COMPONENTS OF A LISTERIA ENVIRONMENTAL MONITORING PROGRAM

Management Commitment

In order for a LEMP to succeed, there must be a top management commitment to the LEMP
program and the overall food safety management system. The success of a LEMP improves
dramatically when senior management drives implementation by establishing regular reviews of
key performance indicators, corrective actions, and continuous improvement results. Moreover,
success depends on detailed planning that provides resources and definition of roles and
responsibilities to empower trained employees to carry out their mission. Roles and
responsibilities should be defined for both operational requirements and management framework
to support the success and effectiveness of the LEMP.

While top management commitment to a LEMP to aid in producing safe food is necessary for
success, effective implementation within the organization is no less critical. Making a public
commitment to all food safety preventive controls and programs is a decisive step in
communicating the importance of such activities to every employee in the organization. Once
food safety management systems become the expected mode in which people work within an
organization, they will become the core of any initiative launched by that group including a LEMP.
All levels of management, from the top down, should have job descriptions defining their
responsibilities for food safety, including LEMP programs, furthered by training to set expectations
for participation, along with how and what to communicate internally and externally.

Senior company officials must further recognize their responsibility to the LEMP by providing for
on-going review and evaluation of the program.

Industry success stories have shown that organizations with a strong food safety management
system as a daily operating philosophy have an advantage in the deployment and implementation
phase of programs like LEMP. One should not underestimate the importance of having both a
strong management system and a robust food safety program for the success of the deployment
and implementation of the LEMP.

The International Organization for Standardization (ISO) defines a system as “a set of interrelated
or interactive elements” and a management system as “a system to establish policy and
objectives and to achieve these objectives”. Using these definitions collectively, a management
system is recognized as “establishing policies and objectives to manage processes” so that each
level of responsible manager and front-line worker understands their role and responsibilities.
Management commitment to the overall food safety system, including LEMP control practices, is
vital to ensuring that food safety hazards that may be reasonably expected to occur are identified,
evaluated, and controlled in such a manner that the product does not directly or indirectly harm
the consumer. The importance of both cannot be overemphasized.

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It is advantageous to form a Food Safety Team within a facility or an organization, which is a
cross-functional team with technical knowledge of the plant’s programs, processes and practices
for achieving effective food safety systems. This team’s responsibility includes developing and
implementing SOPs for prerequisite programs and Hazard Analysis Critical Control Point (HACCP)
plans and FSPs, reviewing related records, verifying practices related to food safety, managing
changes in products and the facility, and employee training. The team leader is often a site
manager at the facility and is accountable to designate each member’s responsibility.

Risk Consideration: Is a LEMP Recommended?

When deciding to implement a LEMP, a risk consideration should be undertaken. The outcome
will determine if a LEMP is recommended. The FDA defines risk as the likelihood of the
occurrence and the magnitude of the consequences of exposure to a hazard on human health
(3).

As stated previously, at-risk foods refer to refrigerated RTE foods that are exposed to the
processing environment and support the growth of L. monocytogenes within the shelf life of the
product. The rationale for differentiating foods that support the growth of L. monocytogenes from
those that do not is based on the results of a 2004 risk assessment conducted by the World Health
Organization (11). This risk assessment concluded that the potential for growth of L.
monocytogenes within the food strongly influences the risk of contracting listeriosis. For instance,
L. monocytogenes cannot grow on low moisture foods (water activity <0.85); therefore, this
product category presents a very low risk of listeriosis (12). The use of LEMP in facilities
manufacturing low moisture foods or other low-risk foods would not be a good use of food safety
resources. A Salmonella EMP may more appropriately be the focus in some of these facilities,
such as those producing low moisture foods exposed to the environment post-lethality. Refer to
the GMA Control of Salmonella in Low-Moisture Foods Guidelines (13).

Product categories NOT typically considered to be at-risk foods generally include:

1. Shelf-stable products (e.g., canned, retorted, acidified, low water activity).

2. Perishable products that allow the growth of L. monocytogenes but have no or very limited
exposure to the plant environment after a lethality step (for example, hot-filled or
pasteurized product).

3. Perishable products with intrinsic characteristics or formulations that prevent the growth
of L. monocytogenes (e.g., acidified refrigerated, listeriostatic/listeriocidal additives).

Product categories considered to be at-risk foods generally allow for the growth of Listeria spp.
at some point prior to consumption and generally include:

1. Refrigerated, perishable foods that are exposed to the plant environment after the final
lethality step.
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 2. Frozen foods exposed to the plant environment after the final lethality step and intended
to be thawed for an extended time prior to consumption (e.g., deli sandwiches, baked
goods, salad ingredients).

3. Foods produced with no lethality step (e.g., dips, spreads, salads, fresh produce).

4. Non-packaged product going through cooling equipment.

The product categories above are not a comprehensive list; if the product is not discussed
above the facility must undertake a risk evaluation. Both food safety and regulatory
considerations should be addressed.

Risk Consideration: What Affects the Stringency of the LEMP?

Factors that may increase the sampling frequency or the number of samples taken and/or more
aggressive corrective action could include:

1. A complex process (e.g., extended run cycles, numerous pieces of equipment, multiple
processing lines or multiple handling steps).

2. Marginal or incomplete segregation between pre- and post-lethality operations. Refer to

the GMA Facility Sanitary Design Checklist for further information (14).

3. Lack of sanitary design of equipment. Refer to the GMA Equipment Design Checklist for
Low-Moisture Foods to assess potential harborage sites (15).

4. Product that is being produced specifically for a high-risk group such as hospital patients,
pregnant women, neonates, or the elderly.

5. Special circumstances, described later in this document.

6. Degree of post lethality product exposure to the environment (i.e., non-packaged product
going through cooling equipment).

The risk evaluation should be a written document where identified risks have been considered
and scientifically linked to an overall environmental monitoring program. The risk evaluation
document provides a living history that should be kept current and updated routinely, including
information such as: changes impacting prior risk considerations or risk decisions, special
circumstances, or discovery of root cause not previously identified. Each risk evaluation update
typically has a corresponding LEMP update.

Monitoring for Listeria spp.

Listeria spp. are a broad indicator which, when detected, provide a signal that conditions favorable
for L. monocytogenes growth or survival could exist. The purpose of the monitoring program is
to find where L. monocytogenes could potentially grow or survive. Using a broad indicator group,
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such as Listeria spp., increases the chances of finding these niches and reacting in an effective
manner.

Designing the Routine Monitoring Program

The objective of the routine monitoring program is to detect growth niches in order to initiate
corrective actions before L. monocytogenes can contaminate product contact surfaces (PCS) or
product. The routine monitoring program will typically focus on surfaces in the processing area(s)
where at-risk product is exposed to the environment. Sampling locations are typically designated
into zones based on the proximity to the food (Table 1). The number of samples collected will
differ by zone, the risk to exposed product and the complexity of the production system. The
majority of the sampling locations are typically focused in Zones 2 and 3 to obtain early indication
of Listeria spp. presence in harborage sites or transfer points6. In order to make the best use of
resources and collect relevant data, it is important that processors perform their own facility
specific evaluation to determine the number of samples and frequency of sample collection in
each of the zones. Recommendations for sample numbers and frequency exist in other guidance,
for example the USDA FSIS Listeria Guidance (16).

For at-risk products, the decision of whether and when to conduct Zone 1 (i.e., PCSs) testing
should be based on a risk evaluation of the food (i.e., the ability to support L. monocytogenes
growth and likelihood of causing illness), the food process, the facility, and past environmental
sampling results. In order to make this decision, the facility should assess whether there is a risk
of harborage of Listeria on PCS and whether information from other verification activities question
the hygienic status of a processing line or an increased potential for cross-contamination of the
line. Zone 1 sampling should be representative of all product contact surfaces on that line. The
number of samples to take would be determined by the size and complexity of the line. Under
most conditions Zone 1 testing for Listeria spp. can be implemented without the need for holding
finished product (see section on Investigation and Corrective Actions). This allows facilities to
more aggressively test for the indicator while minimizing disruption to production.

Typically, Zone 4 monitoring is conducted less frequently or for investigational purposes. The
sampling locations typically include surfaces outside the production areas in order to determine if
there is a potential for Listeria spp. to be present in the non-production areas. Sampling non-
production and raw areas may also help to assess the effectiveness of preventive controls
between production areas with different level of risks (e.g., hallway between raw and/or at-risk
product areas).

6 Surfaces that are exposed to cleaning and sanitation and can serve as points of contact facilitating the
transfer of an organism from one surface to another, e. g., gloved hands. Transfer points should not be
growth niches when effective cleaning and sanitizing procedures are used (4).

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In most circumstances, a LEMP should not extend into raw processing areas (e.g., ingredients,
raw meat and fish, and unpasteurized dairy products) as it is assumed these areas are likely
contaminated. Some facilities may not have truly defined raw and RTE areas. In this case the
“all production” room with exposed at-risk product may be included (e.g. fresh cut produce, salad
assembly) as part of the LEMP area.

In the risk evaluation, thorough consideration should be given to the process flow and nature and
intended use of the product. The sampling of interfaces, transition areas or barriers between raw
areas and at-risk product areas is recommended to verify the effectiveness of preventive controls
at maintaining separation. Some examples include the curing area in raw milk cheese production
or the floor in front of a single door oven

Refer to Table 1 for examples of surfaces to include in a plant program.

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Table 1 – Definition of sampling zones and examples of sample sites to include in a LEMP 7.

Sampling Zone Definition Examples of Sample Sites

Conveyor belts and scrapers, tables, holding vats and

Product contact tanks, utensils, gloves and aprons, pumps, valves,
Zone 1 surface (PCS) slicers, dicers, filling/packaging machines, transport
in RTE areas racks, trays, scales, brine chillers, peeler tables, hoppers,
overhead structures prone to condensation formation
over product contact surfaces
Non-PCS in
Exterior of food contact equipment, control panels,
RTE areas with
lubrication points, sides of weigh scales, other areas
Zone 2 close proximity
where potential risk of contamination exists through
to product or
human or equipment interaction
PCS
Non-PCS
outside of Zone
Floors, walls, refrigeration units, drains, floor mats, doors,
1 or Zone 2, but
Zone 3 floor scrubbers, forklifts, traffic pathways into process
still within the
area, overhead piping, wash stations, floor cleaning tools
RTE processing
area

Non-PCS
Production area offices, locker rooms, restrooms,
outside RTE
Zone 4 cafeteria, hallways, trash areas, maintenance shops,
processing
warehouses, corridors of production areas
areas

7 Sampling zones that illustrate areas of highest risk (Zone 1) to lowest risk (Zone 4) for finished product
contamination according to International Commission on Microbiological Specifications for Foods (ICMSF)
(26). Examples of sampling sites were based on ICMSF recommendations and industry experiences. It is
recommended that a facility evaluation be done to identify sampling sites, in order to include potentially
problematic areas. Final determination on Zone 1, 2, or 3 depends on ability for transfer to RTE product
or PCS.

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The food safety team may develop a list of sites that could be sampled in rotation and be
completely covered in a given timeframe, for example, monthly or quarterly. The trained
technician taking the samples should also have the freedom to sample additional sites as
necessary. As mentioned earlier, the sites should be selected based on the potential to harbor
Listeria spp. Examples of sites and potential sources of Listeria spp. are provided in Table 2.

Routine sampling should be performed during production. It is recommended that sampling of

Zones 1-3 take place at a minimum of three hours after the beginning of production, and should
be varied to cover times and shifts across the entire production schedule. Sampling days should
also be varied to represent the entire production schedule. Some samples can only be collected
safely when equipment is not running. In such a case sampling could be done at the end of
production/before cleaning or any other time the equipment is idle and can be locked out and
safely accessed.

Sample site locations should be changed on a periodic basis and the LEMP should be designed
to foster aggressive investigation. Sampling site locations and frequencies may be adapted to
verify hygiene following specific events such as start up, following a shut down, maintenance, or
other events that could affect the environment or equipment hygiene.

Sampling Procedures and General Guidance

Environmental samples should be taken with the intent of finding Listeria spp., if it is present.
Sampling should be done aggressively by covering a large surface and targeting sites that are
most likely to be contaminated. Detailed procedures for collecting environmental samples are
discussed in various references, for example the Compendium of Methods for the Microbiological
Examination of Foods (17) and others (18, 19).

1. Swabbing procedures must be conducted aseptically by trained plant personnel using

hygienic handling practices (hand sanitizing, wearing gloves, etc.). In general,
sampling should proceed from the “cleanest” areas to the “dirtiest” areas to avoid
cross-contamination of the facility (i.e., PCS sites should be sampled first, followed by
non-PCS). A separate sponge or swab should be used per each distinct site.

a. Up to five separate sponges or swabs may be combined into one sample

(“compositing”). Typically, this is done by using a separate sponge for each
site, and then placing up to five sponges into one sample bag for analysis at
the laboratory. This should only be done in a mature program where
positives are rare, as this may delay or confuse corrective action.

b. PCS samples should not be composited with non-PCS samples.

c. Compositing of samples should not be performed during an investigation.

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 2. Sterile sponges are effective for sampling large areas for Listeria spp. testing. Swabs
may be used for small or difficult to access areas. The sampling device should be
moistened with an appropriate buffer solution. The choice of buffer should be made
in consultation with a technical expert, such as the test-kit provider or a microbiologist.
For example, a buffer containing a neutralizing agent should be used if sanitizer
residues are present and may interfere with the test methodology.

a. When sampling large flat surfaces, sponge an area as large as reasonably

possible (e.g., 12 x 12 inches).

b. When sampling irregular or hard to access surfaces, sample the entire area
as indicated by the surface description. Some equipment disassembly may
be necessary for sampling.

3. When sampling small areas (e.g., head screws, small water collection points, screw
holes, threaded surfaces or interior corners of equipment) use of a swab may be
appropriate. Swab the entire area as indicated by the surface description.

4. Other methods such as sampling of rinsate may also be utilized for difficult to reach
areas.

Sample Handling

1. Procedures should be in place to avoid cross-contamination during sampling and

handling as well as to protect sample integrity.

2. After sampling, immediately return the samples to the lab and refrigerate (do not
freeze) to maintain sample integrity until they are tested internally or shipped to an
external testing laboratory.

3. During isolated situations when Listeria spp. swab samples are taken and it is not
possible for the lab to start testing the next day, the samples should be placed
immediately in the refrigerator. Samples should then be shipped with cold packs and
sent out at the next available shipping time on the next business day.

Testing Methods

Samples taken as part of a LEMP may include samples from PCS and non-PCS (Table 1). It is
recommended that all environmental samples be tested for Listeria spp. following methods that
are recognized by competent authorities for the intended product or environmental sample testing,
such as the methods described in the US FDA Bacteriological Analytical Manual Online (BAM)
(18), the USDA Microbiology Laboratory Guidebook (MLG) (19) or by the Organization for
Standardization (ISO) methods (20, 21, 22, 23, 24). It is also suitable to used methods validated
through recognized validation bodies, such as AOAC (25).

15 | P a g e
Evaluation of Results

1. Data should be reviewed by a qualified individual as soon as practical after receipt

from the laboratory.

2. Positive results should lead to investigation and corrective actions.

3. A facility map is recommended to indicate where the sample sites are located and to
map positive results.

4. The food safety team should monitor and review the LEMP data on a regular basis,
looking for trends or patterns. The frequency and depth of review will depend on the
facility.

INVESTIGATION AND CORRECTIVE ACTIONS

Corrective actions should be taken any time Listeria spp. is identified in the processing facility.
The purpose of investigating the results and implementing corrective actions or preventive
measures is to identify the root cause and eliminate the condition(s) that may have resulted in the
presence of Listeria spp. Corrective actions should be initiated as rapidly as possible to eliminate
the potential niche where Listeria spp. could grow or survive. The course of a corrective action
will depend upon the particular situation and actions may escalate depending on persistence.
Here we will describe corrective actions for a first positive finding and repeat positive findings.
The goal is to “seek and destroy” Listeria spp. if it is found in the processing environment. The
transient nature of some contaminations makes it difficult to identify a root cause in every situation.
Multiple simultaneous actions could be necessary to correct the problem. The key is to verify that
the root cause has been eliminated as demonstrated by repeated negative samplings.

Some manufacturers may decide to confirm if a Listeria spp. result is, in fact, L. monocytogenes.
In such cases initiating corrective actions should begin immediately and not wait until final
confirmation test results are received. While speciation of Listeria can provide information on the
relatedness of Listeria spp. isolated from the environment and assist in trending and root cause
analysis, the manufacturer should not have a false sense of security even if L. monocytogenes is
not confirmed. They should continue with the corrective actions and verifications recommended
below.

Investigations

The depth of the investigation will be determined by performing a risk evaluation that will depend
on the type of products (growth potential in products), target consumers, the historical association
of the product type with listeriosis, and other items. This includes consulting scientific information
and literature such as outbreak data (e.g., data provided by the CDC), and published risk
assessments (3, 11). While a positive finding of Listeria spp. through LEMP does not
automatically implicate finished product, particularly in a facility with no historical findings, an
16 | P a g e
investigation followed by corrective actions should be conducted on all positive results in any of
the four sampling zones.

The manufacturer should conduct a risk evaluation to determine if finished products may be
implicated. It would be advantageous to have a pre-assigned team to assist in the investigation
as well as a general pre-determined documented procedure to help direct corrective actions. The
information below can help guide the content that could be included in this procedure. The
investigation should include a review of records as well as direct observations of the positive site
and surrounding areas. The size and extent of the investigation should be determined by the
plant’s food safety team. It is important to remember that by the time the testing results are
received, several days have passed since the samples were taken.

To illustrate potential actions to be taken following a Zone 1 positive(s) for Listeria spp., two
scenarios have been developed (Figures 1-2). These outline actions to follow for holding and
testing products, and other actions to take depending on the product growth potential and
historical association with listeriosis:

Scenario A: If the food does NOT support growth in its marketed state but potentially
there are inherent risks or a history of listeriosis are associated with the product (ice cream,
frozen vegetables).

Scenario B: Growth potential in the product (e.g., soft cheese such as Queso Fresco,
dips such as hummus) or no growth as marketed (products that may normally be under
scenario A, but targeted/marketed to susceptible population.

Recommended corrective actions for each scenario are explained in this section and summarized
in the decision trees (Figures 1-2).

Recommended general activities may include:

1. The food safety team initiates a preliminary investigation to determine potential cause
and/or possible source for the contamination (e.g., water leaks, maintenance activity,
construction). The suspect site and surrounding areas should be examined as part of the
investigation.

2. Conducting investigational sampling by re-sampling the implicated area and other sites
within the surrounding areas, as well as traffic pattern areas as soon as practical prior to
cleaning. Select sites based on the issue at hand; do not necessarily use routine sample
sites. For investigation purposes, single site swabs (i.e., no composite sampling) should
be collected. Precaution should be taken to avoid spreading potential contamination from
the suspect area to other areas in the plant.

3. Sampling to detect if Listeria has transitioned into the next zone. For example, if the
positive is found in Zone 3, Zone 2 sites in the implicated area could be sampled and
17 | P a g e
 tested to verify that Listeria has not spread to areas closer to PCSs, if a positive is found
in Zone 2, Zone 1 testing may be initiated or increased near the implicated area.

4. Increasing sampling frequency, e.g., from weekly to once every two days in Zone 3, from
weekly to daily for Zone 2. In order to resume routine sampling and consider the problem
resolved, at least three consecutive follow-up samples of the problem site should yield
negative Listeria results (or other number of sites deemed suitable by the facility). Three
consecutive negative samples have become the industry standard and has proven to be
successful. The facility may choose to continue to monitor the site that yielded the positive
test results on a routine basis for some time.

5. Reviewing past test results from the affected area for previous Listeria findings and
ascertain if any trends and/or patterns in the data can provide the root cause of the positive
finding and hence guide the corrective actions. Include other data in this review, such as
test results obtained during pre-operational sanitation verification sampling (e.g., aerobic
plate count (APC) and adenosine triphosphate (ATP) testing.

Corrective actions to be taken should be based on an evaluation of the potential for finished
product contamination given the location of the positive site in the plant environment. All
activities and the outcomes associated with corrective action procedures should be verified
and documented.

In some cases, another internal resource, third party consultant, or extension specialist may
be able to provide “a fresh set of eyes” in reviewing the situation.

Response to an Initial Listeria spp. Finding (Zones 1, 2 and 3):

1. If feasible and appropriate, limit access to the area.

a. Re-examine traffic patterns. Where necessary and feasible, limit traffic flows
(including employees, materials and mobile equipment as applicable) through the
area, restrict fork truck movement, redirect high risk traffic patterns from adjacent
areas, etc.

2. Review pertinent records, such as those related to sanitation, good manufacturing

practices (GMPs), maintenance, etc., to be sure that these activities did not contribute to
the positive finding. Take immediate actions to correct any deficiencies based on findings.
These may include:

a. Reviewing and revising cleaning and sanitation practices and frequencies as

appropriate. More frequent spot cleaning and sanitization may be implemented

b. Reinforcing hygienic practices and retraining employees, if necessary.

18 | P a g e
 c. Reviewing production records including downtime, recent repairs, power outages,
equipment changes, personnel changes, product changes and/or process
changes, maintenance records, roof leaks or other special circumstances.

3. Visually inspect equipment for product build-up remaining after cleaning, condensate,
cracks, bad welds, piping dead ends, etc. Inspect the environment for pooling water and
the condition of floors, walls and ceilings. Ask line workers to assess if there have been
any potential issues.

a. Make any appropriate repairs. For example, repair damaged floors/walls and other
structural damage.

b. Reduce water and eliminate water collection points, if present and practical.

4. Thoroughly clean/sanitize the positive site and the surrounding sampled area.

5. The application of heat (superheated steam, hot water, saturated steam) or a sanitation
process to the affected processing equipment can be an effective way to eliminate the
contamination. This process may need to be conducted on a routine basis if
recontamination is likely.

6. If the root cause identified a growth niche associated with processing equipment, the
preferred action is to re-engineer or replace the equipment with a more appropriate design
so that the growth niche is permanently eliminated.

7. In many instances, a root cause may not be apparent following the investigation, for
example in the event of a single positive Listeria spp. finding. If a potential root cause can
be identified following these steps, take corrective action, verify, and complete corrective
actions.

Additional Actions for a Single Listeria spp. Finding in Zone 2

8. Stopping production for sampling followed by sanitation may be appropriate under

certain circumstances where finished product or PCS may be at-risk. Whether or not
production is halted, conduct additional sampling of Zones 1, 2 and 3 sites; these should
include sites upstream and downstream of the initial positive (vector sampling 8 is a
common approach).

9. Whether or not to disassemble potentially implicated processing equipment depends on

the equipment associated with the Listeria finding and how close the site is to finished

8The original Listeria spp. positive sample is considered to be the center of a bullseye; investigational
samples are taken from around this center point using a concentric ring-like pattern. This pattern should
be three dimensional.

19 | P a g e
 product or a PCS. For example, the outside of a cooling tunnel and support frames may
fall into a Zone 2 sampling category and these sites should not affect product contact
surfaces or cause the equipment to be dissembled. Typically, complete equipment
disassembly and sampling is reserved for repeat Listeria findings.

Additional Actions for a Single Listeria spp. Finding in Zone 1

10. Production should be halted as soon as practical and corrective actions should be
implemented.

11. The depth of the investigation and corrective actions will depend on the growth potential
of L. monocytogenes in the product, historical results at the site, and historical association
of the product type with listeriosis.

a. When the product type has no growth potential but the product type has been
associated with listeriosis (Scenario A):

i. When a single Zone 1 Listeria spp. positive result is obtained, and the root
cause is unknown, subsequent production lots manufactured on that line
should be held and further evaluated. Product testing is optional, however,
whenever a product lot is tested, it should be held and only released if the
applicable test result is negative for Listeria spp. or L. monocytogenes (i.e.,
hold and release). If lot acceptance testing for finished product is already
conducted as part of the overall food safety program (e.g., products with a
Listeria specification), intensified product testing may be initiated following
any Zone 1 Listeria spp. positive finding.

ii. If the product test results are negative for L. monocytogenes (or Listeria
spp.), the product can be released. If positive for L. monocytogenes (or
Listeria spp. if testing does not speciate), the product should be
reprocessed by a method validated to eliminate L. monocytogenes.
Otherwise, the product should be destroyed.

b. When the product type has growth potential or no growth in the marketed state but
is targeted to susceptible populations (Scenario B):

i. If a Zone 1 sample is positive, the food safety team should determine if the
product should be released or if it would be more prudent to reprocess by
a validated method to eliminate L. monocytogenes, or if the product should
be destroyed.

ii. When a single Zone 1 Listeria test result is obtained, subsequent

production lots manufactured on that line should be tested. The
recommended sampling plan is ICMSF case 12, n=20 (26). If the product
20 | P a g e
 is intended for a susceptible population, then additional sampling may be
considered.

iii. Whenever a product lot is subjected to testing, the lot should be held and
only released if the product test results are negative for Listeria spp. or L.
monocytogenes (i.e., hold and release).

12. Obtain at least three consecutive negative follow-up samplings before returning to routine
sampling, as per the facilities corrective action procedures.

Response to Reoccurring Positives9 (all Zones)

When a sound control program for Listeria is in place, finding multiple and/or consecutive positives
may indicate that the primary source is a growth niche, where the organism may have become
established and is multiplying. This can lead to an increased risk for spreading the organism and
ultimately process line contamination. Corrective actions outlined below may be followed for
problem resolution.

Response to a Reoccurring Positive in Zone 3

1. It may be useful to map the contamination sites on a layout of the facility to aid in locating
the source of contamination, or at least suggest additional sites to sample. It is critical
that a harborage site, if one exists, be found and eliminated by appropriate cleaning and
sanitizing.

2. Also note and review shared pieces of equipment for different products.

3. Thoroughly re-inspect areas for potential niches (an area that is not easy to clean and
provides the opportunity for nutrient and moisture build up, and incubation time). Intensify
cleaning and sanitation activities around these.

4. Observe handling practices (production, sanitation, maintenance, material handling) and

correct non-hygienic employee practices.

5. When collecting additional environmental samples during an investigation to determine a

general target in searching for the niche, it is recommended that the team evaluate, where
applicable, water and drainage flow(s) and water use in the suspect area. Following the
water flow and investigative sampling along these routes can often lead to a root cause.
Production areas should be maintained as dry as possible during production.

9 When follow-up samples are taken for an investigation of an initial positive, and these follow-up samples
(from the same or nearby location) test positive for Listeria spp.

21 | P a g e
 6. Review conditions and practices for scenarios that could lead to the contamination of RTE
products or the plant environment with Listeria spp. such as inappropriate traffic patterns,
areas with persistent condensate, back-up of floor drains and other scenarios described
in Table 2 (5).

7. One way to eliminate the potential contamination is the application of heat (superheated
steam, hot water etc.) or an effective sanitation process to the affected processing
equipment. If recontamination appears likely, this process may need to be conducted on
a routine basis.

Additional Actions for a Reoccurring Positive in Zone 2

8. If deemed necessary, disassemble the processing line starting from the site where the
positive Listeria spp. result was located, through to the end of the line. Take apart
equipment as necessary to ensure all PCSs are accessible for cleaning and sanitation.
Sample potential harborage areas. Eliminate or repair marginal design issues, and
obvious defective parts (e.g., cracked gaskets or condensation areas). Disassembly
should be undertaken carefully, and sampling should occur from the outside in, being
extremely careful not to spread the contamination. Document the sample sites carefully
to ensure that the growth niche can be identified. Thoroughly clean and sanitize the
equipment and the surrounding areas as the equipment is reassembled, and conduct a
final cleaning and sanitation step on the reassembled equipment.

9. Examine processing equipment and consider equipment redesign if necessary

10. In the case of reoccurring Zone 2 Listeria spp. test findings in related areas, escalated
testing including Zone 1 in areas associated with the Zone 2 positive or product testing
may be warranted. Sampling may need to be intensified in the case of repetitive positives.
In some operations, investigation may involve testing of worst-case samples on the line.
Line samples may be taken at various times and/or from various locations to help pinpoint
potential contamination sites. Investigational samples should be analyzed individually, not
as composites.

11. Molecular subtyping of isolates may be employed to help identify the source.

12. Quantitative analysis of environmental samples, such as (APC/total viable count, Listeria
count, etc.) can be done in conjunction with the qualitative test to help identify the niche.

Additional Actions for a Reoccurring Positive in Zone 1

13. Conduct pre-operational inspections on the line equipment as necessary in the

investigational sampling plan to re-qualify the line. Pre-operational test results should be
obtained and confirmed negative prior to start-up.

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 a. When the product types have no growth potential; however, the product has been
associated with listeriosis (Scenario A):

i. When a single Zone 1 Listeria spp. test result is obtained, subsequent

production lots manufactured on that line should be placed on hold. If
additional environmental samples are positive the product should be
tested. The recommended sampling plan is ICMSF case 11, n=10 (26).

ii. If lot acceptance testing for finished product is already conducted as part
of the overall food safety program (e.g., products with a Listeria
specification), intensified product testing may be initiated following any
Zone 1 Listeria spp. positive finding.

iii. If the product test results and the Zone 1 location are negative for L.
monocytogenes (or Listeria spp. if testing does not speciate), the product
can be released. If positive for L. monocytogenes (or Listeria spp.), the
product should be reprocessed with a method validated to eliminate
Listeria, otherwise the product should be destroyed.

iv. If there are more Zone 1 positives, but the product has tested negative it
may be necessary to:

 Suspend production and consider if product should be shipped in the

event it tested negative, or if it should be reprocessed or destroyed

 Perform a thorough sanitary design review by dismantling equipment

and conducting intensified swabbing and testing.

 Observe and re-assess sanitation practices

v. If the product is positive it should be destroyed or reprocessed using a

validated Listeria monocytogenes kill process. In addition:

 Perform a thorough sanitary design review by dismantling equipment

and conducting intensified swabbing and testing.

 Observe and re-assess sanitation practices.

b. When the product has growth potential or no growth potential but is targeted to
susceptible population (Scenario B):

i. If a Zone 1 location is positive, the food safety team should determine if the
product should be released, reprocessed with a validated method to
eliminate L. monocytogenes, or destroyed.

23 | P a g e
 ii. Continue to test subsequent production lots manufactured on that line. The
recommended sampling plan is ICMSF case 12, n=20 (26).

iii. Whenever a product lot is subjected to testing, the lot should be held and
only released if the product tests results are negative for Listeria spp. or L.
monocytogenes (i.e., hold and release).

iv. If the product test results and Zone 1 location are negative for L.
monocytogenes (or Listeria spp.), the product can be released. If positive
for L. monocytogenes (or Listeria spp. if testing does not speciate), the
product should be reprocessed by a method validated to eliminate Listeria,
otherwise the product should be destroyed.

v. If there are more Zone 1 positives or the product is positive, it may be

necessary to:

 Suspend production and consider if product should be shipped in the

event it tested negative, reprocessed, or destroyed

 Perform a thorough sanitary design review by dismantling equipment

and conducting intensified swabbing and testing.

 Observe and re-assess sanitation practices

Table 2 contains examples for meat products but the “Equipment or area” and the “Source” listed
applies to other product categories as well.

Documentation

1. Each facility producing at-risk product should have a written facility specific LEMP that
includes general steps to be followed in the event of positive findings.

2. Document all LEMP monitoring activities. These could include the date, time, zone,
line, and sampling location (may include condition of location).

3. Documentation should be reviewed and maintained as per company policy.

4. Document corrective action activities and outcomes. Document all test results and
corrective actions to close out the incident. The documentation demonstrates due
diligence and can also serve as a reference should a similar incident surface.

5. Document updates and changes to the LEMP.

24 | P a g e
Figure 1 Scenario A (Zone 1 positive for Listeria spp.): No growth in marketed state but
intrinsic risks or history of listeriosis (e.g., ice cream, frozen vegetables).

When sampling Zone 1 conducted

 Finished product hold pending results optional

No
Zone 1 positive Return to routine/standard sampling
for Listeria spp.?

Yes

Initiate Root Cause Analysis Investigation and

Corrective Actions
 Follow guidance provided under “initial
positives” (see pages 18-21)
 Take individual environmental samples of
the positive site and vector sites
 Placing finished product on hold until swab No
results are available is optional
Yes

No Release Finished
Is this the 3rd
Repeat Zone 1 positive Product and proceed to
consecutive set of
for Listeria spp.? the next set of follow up
negative results?
environmental samples
Yes

Continue Root Cause Analysis Investigation and Corrective

Actions
 Follow guidance provided under “Reoccurring positives” (see
pages 21-24)
 Increase sampling of the positive site and vector sites
including pre- and post-sanitation.
 Test and hold finished product for Listeria spp. or L. No
monocytogenes (suggested ICMSF case 11, n=10)
Yes

No
Release finished product
Additional Zone 1 or Is this the 3rd
and proceed to the next
finished product consecutive set of
set of follow up
positive? negative results?
environmental samples
and product testing
Yes

Re-occurring positive
 It may be necessary to suspend production and
25 |consider
P a g eif it should be destroyed / re-processed
 Perform a thorough sanitary design review by
dismantling equipment and intensified sampling
 Observe and re-assess sanitation practices
Figure 2. Scenario B (Zone 1 positive for Listeria spp.): Growth potential in product or no
growth as marketed but targeted to susceptible population.

Sampling of Zone 1
 Every lot of product is held.


Zone 1 or product positive for

No
Return to routine/standard sampling
Listeria spp.?

Yes
Yes
 Initiate Root Cause Analysis Investigation and Corrective No
Actions in response to Listeria spp. finding (see pages 18-
21)
 Consider if the product should be destroyed or
reconditioned if Zone 1 positive
 Destroy or recondition the product if the product tests Minimum of three
positive successive negative
 Take individual samples of the positive site and intensified samplings be achieved for
sampling of other Zone 1 sites from the line pre- and post- the specific incident to be
sanitation considered as resolved.
 Continue to place finished product on hold and test
(recommend ICMFS case 12, n=20) for Listeria spp. and
L. monocytogenes.

No Release finished product

Repeat Zone 1 or
product positive? and proceed to the next
set of follow up
environmental samples
Yes

 Hold affected finished product and test (recommend ICMFS

case 12, n= 20)
 Continue Root Cause Analysis investigation and take additional
corrective actions to address (see pages 21-24)
 Destroy or recondition the product if the product is positive
 If Zone 1 repeat positive, it may be necessary to suspend
production and consider if product should be shipped in the
event it tested negative or if it should be destroyed or
reconditioned
 Perform a thorough sanitary design review by dismantling
equipment and intensified swabbing
 Observe and re-assess sanitation practices

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Table 2 - Examples of sources of contamination by Listeria species or Listeria-like10 organisms
in RTE-food-processing operations and corrective actions that were taken (1989-2000) (5).

Source(s) of
Equipment or contamination (i.e.,
Corrective action(s) taken
area niches or other sites of
growth)

Continuous brine Sponge rubber seals Rubber seals were removed;

chill chamber for around edge of doors at doors were redesigned so that
product top and side of chill unit seals were not needed
suspended from
smoke sticks

Hopper that Cinder blocks around Cinder blocks were sealed to

catches franks opening in wall between prevent moisture from
after peeling peeler room and accumulating in the blocks;
packaging room stainless steel lip was installed
around top of opening to divert
moisture down the side

Continuous brine Doors made of rubber- Doors were replaced with rigid
chill chamber for coated fabric, large metal clean-able plastic material; large
product on racks hinges extending the hinges and bump guards were
with wheels width of the door, and removed
hollow bump guards at
bottom of door

Ammonia unit Fiberglass insulation on Contaminated insulation was

used to chill brine ammonia line to brine removed; pipe and area were
solution chilling unit became satu- cleaned and sanitized; insulation
rated with brine was not placed too close to pipe
splashing from chilling to brine chiller
unit

Refrigeration unit Condensate from Refrigeration unit was cleaned

near ceiling of refrigeration unit and sanitized. To prevent
holding cooler reoccurrence, the unit was placed
before peeling on the master sanitation schedule

Area of brine chill Hoses and spray nozzles Hoses and nozzles were
exit and peeler at exit end of brine chill replaced; daily cleaning was
tunnel used to spray initiated
down franks for easier
peeling

10A colony that displays Listeria-like colony morphology on selective agar such as Modified Oxford Agar,
however the colony is not confirmed as Listeria spp. or L. monocytogenes.

27 | P a g e
 Source(s) of
Equipment or contamination (i.e.,
Corrective action(s) taken
area niches or other sites of
growth)

Collator and Undetermined Equipment was covered with

conveyor large tarp and steam was
injected. To prevent
reoccurrence, the equipment was
re-designed to facilitate cleaning
and inspection

Peeler area Overhead on/off valves Area was included in daily

for steam and water lines sanitation program
near peeling equipment

Peeler area Peeler Peelers were modified for ease

(multiple events) and effectiveness of cleaning;
centralized casing removal
systems were installed to avoid
operator contact with spent
casings; metal boxes with steam
ports were built so that peelers
could be steamed each day
before start of operation

Incline conveyor Two-ply Plexiglas shield Plexiglas was replaced with

leading out of guard on underside of stainless steel guard
peeler room into conveyor had a crack
packaging area where meat particles
became entrapped

Brine chill Construction of brine chill Framing was modified to facilitate

tunnel had stainless steel cleaning and to prevent material
framing with metal from getting into the space
touching metal, causing
an unclean-able space

Incline conveyor Contaminated liquid was Hollow sprocket was replaced

leading from discovered within a with solid sprocket
peeler room to hollow split sprocket
packaging area

Wall in peeler Insulation behind All fiberglass/insulation was

room fiberglass wall was removed from wall; concrete wall
contaminated by was cleaned with an acid base
condensate from cleaner, sanitized, and sealed:
overhead pipe(s) overhead pipes were rerouted to
be closer to the floor

28 | P a g e
 Source(s) of
Equipment or contamination (i.e.,
Corrective action(s) taken
area niches or other sites of
growth)

Casing removal Design made cleaning System was rebuilt to shorten

system (a long difficult; inadequate length, replace existing pipe with
pipe through which cleaning and sanitizing stainless steel, and remove
vacuum conveys deadends and 90° angles;
casings from the training and education were
peeler to a can- provided to supervisor and
ister in another cleaning person
room)

Slicer Worn hydraulic seals at Slicer was stripped, cleaned,

base of slicer, oil with sanitized, and placed into oven,
water and product where moist heat was applied;
residue seals were replaced; slicer was
put on preventive maintenance
schedule; oil was used with
listericidal additive (sodium
benzoate)

Slicing/packaging Can opener with heavy Cover was modified so that it

line wire safety cover could be removed daily for
cleaning (Occupational Safety &
Health Administration (OSHA)
had required that it not be
removable for employee safety)

Slicer Buildup inside safety Cover was changed so that it

cover over gear and could be removed for cleaning
drive belt; material from each night
this site contaminated
product conveyor located
below

Dicer (multiple Undetermined Dicer was placed into oven and

events) moist heat was applied, or dicer
was covered with tarp and steam
was applied

Packaging Crack in stainless steel Area was cleaned, sanitized, and

machine covering on top edge of welded
the packaging machine
near loading area

29 | P a g e
 Source(s) of
Equipment or contamination (i.e.,
Corrective action(s) taken
area niches or other sites of
growth)

Conveyors Hollow rollers Hollow rollers were replaced as

(multiple events) detected; where possible,
conveyors were replaced with
sloping stainless steel slides

Brine chill tunnel Damaged rubber seals Damaged door seals were
for product on on stainless steel door at replaced; cleaning procedure was
hanging racks exit of tunnel modified

Conveyor between Worn conveyor made of Conveyor was replaced with one
shrink tunnel and rubber-coated fabric of new material
boxing

Conveyor leading Fabric conveyor belt Belt was replaced with stainless
to packaging material steel slide
machine

Cooked product Hand-held knives for Knives were cleaned and

stripping area opening product sanitized daily in an automatic
washer and were not stored in
lockers

Bagging table Air duct at base of table Table was modified to make duct
for blowing bags open accessible for nightly cleaning

Exit conveyor from Wheel bearings for Wheel bearings were removed
spiral freezer conveyor belt and replaced

Spiral freezer Undetermined Cleaning frequency was

increased and equipment was
allowed to defrost before cleaning

Between freezer Overhead conveyor Safety ladder was provided so

and packaging that conveyor could be cleaned
machine from above rather than from
below

Wire mesh Hollow support rods for Hollow support rods were
conveyor between conveyor replaced with solid support rods
oven and freezer

Packaging Stainless steel rods for Push rods were removed,

machine pushing product into cleaned, and sanitized on daily
carton basis

30 | P a g e
SPECIAL CIRCUMSTANCES
Environmental monitoring may need to be intensified to verify effective Listeria spp. control when
a special event or circumstance occurs. All operations will experience both planned and
unplanned production interruptions. Such circumstances include, but are not limited to:

1. Planned events: such as construction, equipment installation, major repairs, a high

number of temporary workers, the change of sanitation from in-house to a third-party
sanitation crew or vice versa, major change in production system or startup of different
types of products in the facility.

2. Unplanned events: may include water leaks (drain backup, burst pipes, leaking roofs, fire
sprinkler, etc.), major hygienic zones breach, fires, natural disasters, etc.

When a special circumstance occurs, the facility should consider increasing the intensity of the
environmental monitoring program by selecting additional sampling sites, increasing the number
of samples and/or increasing the frequency of sampling. Refer to the Investigation and Correction
Action section on page 14 for guidance on increased sampling. Such an increase in sampling
(the number of sites, the number of samples and frequency) would depend on the risk evaluation.
Environmental monitoring should be initiated in the area where the events or activities occur (if
the area is not already included under routine monitoring). Several examples of approaches taken
to address special circumstances are provided below.

Monitoring the special circumstances area:

1. Consider taking additional Listeria spp. environmental samples within or adjacent to the
activity site. Samples can be taken while the activity is occurring throughout the duration
of the activity. If any of the swabs are positive for Listeria spp., the plant food safety
team should determine, carry out and document appropriate corrective actions (See
Investigations and Corrective Actions section).

2. Take action(s) to prevent the event from reoccurring.

3. When the special circumstance is completed and the food safety team has determined
that it is appropriate to return to routine monitoring, the team may want to continue some
additional monitoring to verify that the event has not created any long term issues.

4. For unplanned events, consider investigational sampling to assess the impact on

production areas and evaluate the effectiveness of those interim mitigation actions until
permanent corrective action(s) can be implemented.

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Roof and Water Leaks in Exposed RTE Product Areas

In the event of roof and/or overhead water leaks occurring in close proximity to product contact
areas or exposed product, plant employees should report the conditions immediately to
appropriate management personnel. The plant food safety team will identify the need for
additional environmental monitoring, if any (e.g., product and/or non-product contact Listeria spp.
testing), based on the evaluation of contamination risk. The product should be evaluated for
potential contamination and actions taken accordingly.

Plant Construction or Equipment Installation

In the event of plant construction and/or equipment installation or recommissioning of equipment

that has been idle for a while, in RTE areas, increased environmental control procedures and
action steps may be warranted.

When sampling for Listeria spp. while the plant is undergoing construction, consideration should
be given to sampling during construction and sampling of adjacent areas. Increased frequency of
sampling and number of sample sites should be considered following construction, after
equipment installation and after major repairs are completed. In order to determine sampling sites
and swabbing frequencies, the plant food safety team may assess items such as:

1. Plant traffic controls

2. Sanitation activities during construction

3. Plant location of construction activities

4. Type of construction (e.g., installation, demolition, material removal, etc.)

5. Time duration of construction activities

6. Types of environmental controls implemented

Drainage Backups

Drains backing up may increase the risk for environmental contamination in sensitive areas from
two sources. First, drains are inherently dirty and liquids seeping from drains into a processing
area could carry microbial contaminants. Secondly, if the facility is not designed such that all
drain water flows from cleanest to the dirtiest portions of the factory, non-RTE wastes could also
back up into RTE areas. In such situations food safety management should consider, in addition
to other control measures, increasing environmental monitoring in an affected area after the
situation has been corrected.

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Other Operational Issues

Both planned and unplanned events may further express the need for increased LEMP activity.
These can include, but are not limited to, changes in Sanitation Standard Operating Procedures,
non-RTE ingredients being discovered in RTE areas, breakdown in zoning practices, and traffic
pattern disruptions.

Recommended Practices

All operations will experience both planned and unplanned production interruptions.
Unfortunately, some special circumstances such as fire sprinkler malfunctions or drains backing
up are unforeseen events that can impact food safety during processing and storage. However,
in other instances the special circumstance may be a planned event such as construction, major
equipment overhaul(s) or major changes in production systems. When the interruptions are a
planned event, food safety management should ensure that a microbial baseline of the
appropriate area exists. If such a baseline does not exist, they should take steps to establish
that baseline before the special circumstance ensues. Baseline data should be collected over a
series of different production days and at different times of the day. During and/or after the
special circumstance, environmental monitoring results can then be compared against the
baseline to detect if an unusually high amount of Listeria spp. positives are occurring and apply
corrective actions as appropriate.

Natural disasters such as hurricanes and tornadoes can have a significant effect on
environmental systems and infrastructures. When the food manufacturing facility has been
impacted by such a disaster, the food safety team should evaluate the situation and determine if
a change in environmental monitoring procedures is warranted. This evaluation could include
factors such as structural damage, waste stream efficiency, flood damage and the availability of
power and potable water. From this evaluation, the food safety team can determine the steps for
environmental evaluation, if any. Each case may be slightly different and may require more or
less environmental testing.

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VERIFICATION OF A LISTERIA ENVIRONMENTAL MONITORING PROGRAM
The adequacy of the LEMP should be reviewed on an ongoing basis (e.g., every 1-2 years) to
assure that the program is effective and to drive continuous improvement. These validation and
verification activities should be documented. In the U.S., the proposed regulations on Current
Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for
Human, 21 CFR Part 117 (8) and Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Food for Animals, 21 CFR Part 507 (27), include specific
requirements for verification and validation activities related to food safety controls.

Environmental Monitoring Program Validation

Typically, validation activities include those that would be used to demonstrate that the
mitigation(s) employed at a HACCP/FSP critical control point is effective. In the strictest
sense/definition, validating a LEMP would involve inoculating the environment with the target
pathogen or suitable surrogate and demonstrating that the monitoring program is effective in
identifying the presence of the target organism and that corrective action can eliminate it. In the
typical manufacturing environment, this is not an acceptable approach.

Other validation strategies may also include referencing existing scientific literature, the use of
predictive modeling, or historical data. Certain elements of the program can be validated in a
traditional sense, such as testing methodology. GMA suggests that when traditional validation is
not feasible, procedures implemented as part of a LEMP should be technically sound, i.e., based
on industry best practices. For example, environmental sampling plans, such as sample number
and location, may not be statistically designed but are based on facility history and experience
and knowledge of the sites most likely to detect a failure in good hygiene practices (26).

Environmental Monitoring Program Verification

Verification of the LEMP is a routine process involving the review of all program elements, results,
corrective actions and documentation. It includes visual observation of the program execution to
ensure that all required steps are performed properly and completely.

Verification of the LEMP may include activities specific to a line/area or to the overall program:

1. Methodology Review

a. Does the monitoring program include the appropriate numbers of samples, site
locations and time of sampling?

b. Is the proper sampling procedure being followed and correct location being
sampled by the technician(s)?

c. Were samples handled and delivered to the lab in an appropriate manner?

34 | P a g e
 d. Review of analytical methods (e.g., is the correct method used, is the method being
followed correctly?)

2. Record and Results Review

a. Are documents/records and reported results (including required review/sign-offs)

accurate and complete?

b. Are there documents/records of appropriate response to findings and corrective

actions?

c. Have periodic reviews of results identified any trends or repeat issues?

d. Were corrective actions implemented and followed?

e. Do records show the corrective actions effectively re-established control?

3. Are Sampling Tactics Modified in Response to:

a. Results/trends/repeat issues?

b. Special circumstances?

c. Changes to product, process, equipment and/or plant environment?

During the verification activities, additional sampling may be conducted to look at more and/or
different sites to demonstrate that routine sampling has been effective. Finished product testing
may also be utilized. Other activities such as use of an outside expert consultant or reliance on
published materials can also be of value.

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CONCLUSION AND SUMMARY
Listeria monocytogenes, being widely distributed in nature, has the potential to find harborage in
many types of food processing facilities and has been associated with outbreaks across various
food categories. Therefore, manufacturers of all types of food products should conduct a risk
evaluation to determine if a Listeria Environmental Monitoring Program is appropriate for the
specific operation. Following the risk evaluation, manufacturers should consider a LEMP if the
processing/sanitation conditions may be favorable to the survival/growth of L. monocytogenes in
at-risk foods.

In the US, the meat industry was among the first to implement an industry-wide program to
address the presence of Listeria spp. in the processing environment as a verification tool to ensure
that control programs are effective in preventing potential cross-contamination of finished
products. Through collaboration with industry associations and regulatory agencies, the meat
industry was able to aggressively pursue a “seek and destroy” approach to identify possible
harborages of the organism. Data published by the CDC show a reduction in the number of
outbreaks involving L. monocytogenes contamination of RTE meat since this approach has been
implemented (1).

One of the key factors for the success of the meat plants’ approach was to take corrective actions
once Listeria spp. was found in the manufacturing environment and monitor the effectiveness of
the corrective action(s). Due to its ability to form biofilms, Listeria spp. may be difficult to remove
and incremental actions may be required to completely eliminate the source.

This guidance is based on industry practices that have demonstrated good results. Manufacturers
should stay informed and modify their programs as new information arises.

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REFERENCES

1. U.S. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly
Report. Vital Signs: Listeria Illnesses, Deaths and Outbreaks – United States, 2009–2011.
Volume 62, June 7, 2013. [Online] http://www.cdc.gov/mmwr/preview/mmwrhtml/m.

2. Little, C. L., S. K. Sagoo, I. A. Gillespie, K. Grant, and J. McLauchlin. 2009. Prevalence

and level of Listeria monocytogenes and other Listeria species in selected retail ready-to-
eat foods in the United Kingdom. Journal of Food Protection, Vol. 72, pp. 1869-1877.

3. U.S. Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, and U.S. Department of Agriculture,
Food Safety and Inspection Service. 2003. Quantitative assessment of the relative risk
to public health from foodborne Listeria monocytogenes among selected categories of
ready-to-eat foods. [Online: Cited April 14, 2014].
http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAsse
ssment/ucm1839.

4. Malley, T. J. V., J. Butts, and M. Wiedmann. 2015. The Seek and Destroy Process:
Listeria monocytogenes Process Controls in the Ready-to-Eat (RTE) Meat and Poultry
Industry. Journal of Food Protection, Vol. 78. pp. 436-45.

5. Tompkin, R. B. 2002. Control of Listeria monocytogenes in the food-processing

environment. Journal of Food Protection, Vol. 65, pp. 709-725.

6. Butts, J. April/May. 2003. Seek and Destroy: Identifying and Controlling Listeria
monocytogenes Growth Niches. Food Safety Magazine, Vol. 31.

7. U.S. Department of Health and Human Services, Food and Drug Administration,
Food Safety Modernization Act (FSMA). Compliance Dates. Page Last Updated: February
2, 2018. [Online: Cited February 5, 2018].
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm540944.htm

8. Code of Federal Regulations. 2015. Current Good Manufacturing Practice, Hazard

Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule. 21 CFR Parts
117. [Online: Cited February 5, 2018].
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11
7.

9. Federal Register. 2013. Vol. 78, No. 11. Proposed Rules. FDA. 21 CFR Parts 1, 16, 106,
110, 114, 117, 120, 123, 129, 179, and 211. Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food. [Online: Cited February
5, 2018]. https://www.gpo.gov/fdsys/pkg/FR-2013-01-16/pdf/2013-00125.pdf.

37 | P a g e
 10. U.S. Department of Health and Human Services, Food and Drug Administration.
2017. Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat
Foods. [Online: Cited February 5, 2018].
https://www.fda.gov/RegulatoryInformation/Guidances/ucm073110.htm

11. World Health Organization. Risk assessment of Listeria monocytogenes in ready-to-eat

foods. 2004. [Online: Cited April 12, 2014].
http://www.who.int/foodsafety/publications/mra4-risk-listeria/en/.

12. Beuchat, L. R., E. Komitopoulou, H. Beckers, R. P. Betts, F. Bourdichon, S. Fanning,

H M. Joosten, and B. H. Ter Kuile. 2013. Low-Water Activity Foods: Increased Concern
as Vehicles of Foodborne Pathogens. Journal of Food Protection, Vol. 76, pp. 150-172.

13. Grocery Manufacturers Association. 2009. Control of Salmonella in Low-Moisture

Foods. [Online: Cited January 17, 2018.]
https://www.gmaonline.org/forms/store/ProductFormPublic/SalmonellaControlGuidance.

14. Grocery Manufacturers Association. 2010. Facility Sanitary Design Checklist. [Online:
Cited January 17, 2014.]
https://www.gmaonline.org/forms/store/ProductFormPublic/facility-design-checklist.

15. Grocery Manufacturers Association. 2010. Equipment Design Checklist for Low-
Moisture Foods. [Online: Cited January 14, 2014.]
https://www.gmaonline.org/forms/store/ProductFormPublic/equipment-design-checklist-
for-low-moisture-foods.

16. U.S. Department of Agriculture Food Safety Inspection Service. 2014. FSIS
Compliance Guideline: Controlling Listeria monocytogenes in Post-lethality Exposed
Ready-To Eat Foods. [Online: Cited April 15, 2012.]
http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-
e74a1e549fde/Controlling_LM_RTE_Guideline_0912?MOD=AJPERES.

17. Downes, F. P and K. Ito. 2001. Compendium of Methods for the Microbiological
Examination of Foods, 4th edition. American Public Health Association, Washington, DC.

18. U.S. Department of Health and Human Services, Food and Drug Administration.
Bacteriological Analytical Manual Online. [Online: Cited February 3, 2014.]
http://www.fda.gov/food/foodscienceresearch/laboratorymethods/ucm2006949.htm.

19. U.S. Department of Agriculture Food Safety Inspection Service. Microbiology

Laboratory Guidebook. [Online: Cited April 14, 2014].
http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-
procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/microbiology-
laboratory-guidebookw.

20. International Organization for Standardization. 1996. ISO 11290-1:1996(en).

Microbiology of food and animal feeding stuffs - Horizontal method for detection and
enumeration of Listeria monocytogenes- Part 1: Detection method.

38 | P a g e
 21. International Organization for Standardization. 1998. ISO 11290-2:1998(en).
Microbiology of food and animal feeding stuffs - Horizontal method for the detection and
enumeration of Listeria monocytogenes - Part 2: Enumeration method.

22. International Organization for Standardization. 2004a. ISO 11290-

1:1996/Amd.1:2004(en). Microbiology of food and animal feeding stuffs - Horizontal
method for detection and enumeration of Listeria monocytogenes - Part 1: Detection
method; Amendment 1: Modification of the isolation media and the haemolysis test, and
inclusion of precision data.

23. International Organization for Standardization. 2004b. ISO 11290-

21:1996/Amd.1:2004(en). Microbiology of food and animal feeding stuffs - Horizontal
method for the detection and enumeration of Listeria monocytogenes - Part 2:
Enumeration method; Amendment 1: Modification of the enumeration medium.

24. International Organization for Standardization. 2004c. ISO 18593:2004(en).

Microbiology of food and animal feeding stuffs - Horizontal methods for sampling
techniques from surfaces using contact plates and swabs.

25. AOAC International. 2012. Official Methods of Analysis of AOAC INTERNATIONAL, 19th
Edition. AOAC International, Gaithersburg, MD.

26. International Commission on Microbiological Specifications for Foods (ICMSF).

2002. Sampling to Assess Control of the Environment (pp. 199-224). In Microorganisms
in Foods 7: Microbiological Testing in Food Safety Management. Springer Science, New
York, NY.

27. Code of Federal Regulations. 2015. Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Food for Animals. 21 CFR Parts 507.
[Online: Cited February 5, 2018].
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50
7.

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APPENDIX: SANITARY DESIGN OF EQUIPMENT AND FACILITIES
FDA proposed Hazard Analysis and Risk-Based Preventive Controls for Human Food:
Guidance for Industry, Draft Guidance (1):

Chapter 4 – Preventive Controls

 “Effective sanitary design should consider factors such as whether equipment includes
hollow bodies or poorly developed welds and seams, as well as whether ease of
disassembly allows adequate access to all food-contact surfaces to ensure thorough
cleaning and sanitation.”

 “Sanitary design also applies to food facility structures (e.g., floors, walls, piping, and
ceilings) to… ensure effective cleaning and sanitation practices. The required elements
for cleaning – time, temperature, mechanical force and chemical concentration – simply
cannot be reliably applied if the equipment and facility structural design does not allow
adequate access…”

Many RTE foods are produced in manufacturing processes void of lethality steps. Others may
experience exposure to the factory environment after a lethality step. As mentioned elsewhere,
such exposure has the potential to result in post process contamination by Listeria from the
environment. Consequently, any surface touching food should be as clean as reasonably
possible. This goal is easier maintained when the equipment and processing facility are designed
and installed along sanitary design principles. Proactive sanitary design ensures equipment can
be effectively cleaned and sanitized, and surfaces are resistant to daily exposure to food products
and cleaning/sanitizing chemicals. Equipment that does not meet basic sanitary design
principles, or is installed, maintained or used improperly, is more difficult to adequately clean and
sanitize. and hence is more likely to become a Listeria harborage.

Guidelines for sanitary fabrication, construction, and design of food facilities and equipment have
been developed by a variety of organizations. While there are subtle differences between these
standards, the primary focus of each group is the employment of fundamental sanitary principles
in both food equipment and facility design. GMA has developed two sanitary design checklists,
one for equipment and another for facilities, which can be accessed for no cost at GMA’s website
(2, 3). Other organizations with sanitary design standards include the American Meat Institute
(4), the USDA Agricultural Marketing Service (AMS) Equipment Review (5), which includes
guidelines for the sanitary design of dairy processing equipment (6) and meat and poultry
processing equipment (7) and 3-A Sanitary Standards, Inc (8). In Europe, the European Hygienic
Design Group (EHEDG) is one of the primary organizations for food equipment approval. The
contents of all EHEDG guidelines have been cross-referenced with those of 3-A Standards Inc.
and are summarized in a matrix available for download (Microsoft Excel file format) (9). Both
organizations exchange their draft guidelines and standards for expert review and comments

i
before publication. EHEDG documents can be found in several languages at their website (10).
Other standards may also be available.

Regardless of whether a facility chooses to use an existing standard/guidance, or develop their

own protocols, evaluation of sanitary equipment design for product and non-product contact
surfaces could include:

 Cleanability of equipment surfaces,

 Compatibility of surfaces with the food, cleaning/sanitation chemicals, steam, the

environment etc.,

 Accessibility of the equipment for cleaning, inspection and maintenance,

 Lack of liquid collection: equipment that is self-draining, made of non-absorbent

materials etc.,

 Hollow areas on the equipment are hermetically sealed,

 A lack of microbial niches,

 Sanitary operational performance including design of maintenance enclosures, and

hygienic compatibility with other factory systems (i.e., exhaust, dust collection, air supply
for both fresh and compressed air, etc.),

 Implementation of effective cleaning protocols, and

 Hygienic installation.

Evaluation of hygienic facility design may include:

 Distinct hygienic zones are established in the facility (i.e., raw vs. cooked, RTE vs.
NRTE, storage vs. processing etc.),

 Personnel and material flows are controlled to reduce hazards,

 Controlled water usage and accumulation,

 Controlled air flows: room air flow and room air quality controls,

 Site elements facilitate sanitary conditions,

 Building envelopes (i.e., shell, roof, and skin) facilitate sanitary conditions,

 Interior spatial design promotes sanitation,

 Utility systems are designed to prevent contamination, and

ii
  Integration of sanitation principles incorporated into facility design.

For further details on any of these specific principles please see the GMA Equipment Design
and GMA Facility Design checklists at GMA’s website (2, 3).

REFERENCES
1. U.S. Department of Health and Human Services, Food and Drug Administration.
2016. Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft
Guidance for Industry. [Online: Cited February 5, 2018].
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulat
oryInformation/UCM517417.pdf

2. Grocery Manufacturers Association. Facility Sanitary Design Checklist. 2010. [Online:

Cited January 17, 2014.]
https://www.gmaonline.org/forms/store/ProductFormPublic/facility-design-checklist.

3. Grocery Manufacturers Association. Equipment Design Checklist for Low-Moisture

Foods. 2010. [Online: Cited January 14, 2014.]
https://www.gmaonline.org/forms/store/ProductFormPublic/equipment-design-checklist-
for-low-moisture-foods.

4. American Meat Institute. 2014. Sanitary Equipment Design Principles, Checklist &
Glossary. [Online: Cited January 23, 2018].
https://www.meatinstitute.org/ht/a/GetDocumentAction/i/97261.

5. U.S. Department of Agriculture Agricultural Marketing Service. Equipment Review.

[Online: Cited January 23, 2018].
https://www.ams.usda.gov/services/auditing/equipment.

6. U.S. Department of Agriculture Agricultural Marketing Service. 2001. USDA

Guidelines for the Sanitary Design and Fabrication of Dairy Processing Equipment.
[Online: Cited January 23, 2018].
https://www.ams.usda.gov/sites/default/files/media/USDA%20Guidelines%20for%20the
%20Sanitary%20Design%20and%20Fabrication%20of%20Dairy%20Processing%20Eq
uipment.pdf.

7. U.S. Department of Agriculture Agricultural Marketing Service. 2009. USDA

Guidelines for The Evaluation and Certification of the Sanitary Design and Fabrication of
Meat and Poultry Processing Equipment. [Online: Cited January 23, 2018].
https://www.ams.usda.gov/sites/default/files/media/Guidelines%20for%20the%20Evaluat
ion%20and%20Certification%20of%20the%20Sanitary%20Design%20and%20Fabricati
on%20of%20Meat%20and%20Poultry%20Processing%20Equipment.pdf.

8. 3-A Sanitary Standards, Inc. [Online: Cited January 23, 2018]. www.3-a.org.

9. European Hygienic Design Group. Harmonization of EHEDG guidelines and 3-A

standards. [Online: Cited January 23, 2018].
https://ehedg.tw/fileadmin/user_upload/2017_12_3-A_EHEDG_Matrix.xlsx.

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10. European Hygienic Design Group. Guidelines. [Online: Cited January 23, 2018].
https://www.ehedg.org/guidelines/.

iv