Listeria Control

Checklist for Frozen

Vegetable Operations
Version 1.01, January 23, 2017
Table of Contents
Table of Contents .......................................................................................................................................... 2
Frozen Vegetable Workgroup ....................................................................................................................... 4
Introduction .................................................................................................................................................. 5
Definitions ..................................................................................................................................................... 7
Part 1: Basic Listeria Control Strategies for Food Processing ....................................................................... 8
Sanitary Design of Facilities and Amenities .............................................................................................. 8
General .................................................................................................................................................. 8
Grounds................................................................................................................................................. 8
Facility ................................................................................................................................................... 8
Walls, Floors and Drainage, Ceilings ..................................................................................................... 8
Traffic Patterns...................................................................................................................................... 8
Fixtures, Ducts, Plumbing, Lighting ....................................................................................................... 9
Air Flow Quality and Patterns ............................................................................................................... 9
Construction, Plant Improvement, Maintenance Projects ................................................................. 10
Sanitary Design of Equipment & Utensils ............................................................................................... 11
General ................................................................................................................................................ 11
Equipment and Infrastructure ............................................................................................................ 11
Utensils................................................................................................................................................ 11
Food Contact Surfaces ........................................................................................................................ 11
Cleaning, Sanitation and Maintenance Practices ................................................................................... 13
General ................................................................................................................................................ 13
Pre-operative Sanitation ..................................................................................................................... 13
Operative Sanitation ........................................................................................................................... 13
Grounds............................................................................................................................................... 14
Maintenance ....................................................................................................................................... 14
Environmental Monitoring Considerations ............................................................................................ 16
Environmental Sample Collection and Handling................................................................................. 16
Water Use in the Production Area .......................................................................................................... 17
Water Supply....................................................................................................................................... 17
Water Control ..................................................................................................................................... 17
Good Manufacturing Practices and Personal Hygiene ........................................................................... 18
Employee Training .............................................................................................................................. 18

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 Good Manufacturing Practices ........................................................................................................... 18
Personal Hygiene ................................................................................................................................ 18
Part 2: Control Strategies for High Care Frozen Vegetable Operations...................................................... 20
Sanitary Design of Facilities and Amenities ............................................................................................ 20
Facility Design ..................................................................................................................................... 20
Traffic Patterns.................................................................................................................................... 20
Fixtures................................................................................................................................................ 21
Air Flow Quality and Patterns ............................................................................................................. 21
Sanitary Design of Equipment and Utensils ............................................................................................ 23
Equipment and Infrastructure ............................................................................................................ 23
Utensils................................................................................................................................................ 24
Cleaning and Sanitation Practices ........................................................................................................... 25
General ................................................................................................................................................ 25
Pre-operative Sanitation ..................................................................................................................... 25
Operative Sanitation ........................................................................................................................... 27
Environmental Monitoring Considerations ............................................................................................ 28
The Environmental Monitoring Plan ................................................................................................... 28
Sample Collection ............................................................................................................................... 28
For Cause Investigation ....................................................................................................................... 29
Not For Cause Investigation ................................................................................................................ 30
Water Control in the Production Area .................................................................................................... 31
Good Manufacturing Practices and Personal Hygiene ........................................................................... 33
Personal Hygiene ................................................................................................................................ 33
Good Manufacturing Practices ........................................................................................................... 34
Appendix I. Sample Swab Test Procedure .................................................................................................. 35
Appendix II. Sample Environmental Foodborne Pathogen Surveillance .................................................... 37
Appendix III. FDA Investigations Resources ................................................................................................ 41
FDA Investigations Operations Manual .................................................................................................. 41
FDA Regulatory Procedures Manual ....................................................................................................... 41
FDA Compliance Policy Guides ............................................................................................................... 41
FDA Inspection Observations .................................................................................................................. 41
References .................................................................................................................................................. 43

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Northwest Food Processors Association

Frozen Vegetable Workgroup

Debbie Radie, Boardman Foods

Todd Badgley, ConAgra Lamb Weston

Robert Beck, NORPAC Foods

Amanda Pederson, NORPAC Foods

Mark Hooper, Pinnacle Foods

Mark Clute, Rainsweet Co.

Larry Mulenberg, Seneca Foods

Kevin Browning, J.R. Simplot Co.

Duane Evans, J.R. Simplot Co.

Kathy Nelson, J.R. Simplot Co.

John O’Grady, Twin City Foods

Glenn Strachan, Twin City Foods

Connie Kirby, Northwest Food Processors Association

David McGiverin, Northwest Food Processors Association

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Introduction
This checklist was developed to assist frozen vegetable manufacturers in conducting a comprehensive
audit of control measures for Listeria monocytogenes (Lm) in their operations. It is designed to
correspond as a checklist to the principles laid out in “Best Practices for Prevention and Control of
Listeria monocytogenes in the Post-Lethality Environment.” developed by NWFPA collaborative partner,
the American Frozen Food Institute. It is based on the current science available at the time of
publication. As research in Lm control in food processing facilities is expanding rapidly, readers should
expect this document to evolve as best practices develop.

The document was created in an internal audit format. It is comprised of a comprehensive set of
questions, developed by industry food safety professionals, that a firm can be asking about Listeria
control measures employed in their facility. However, as firms must tailor their food safety systems to
each facility, not all the items in the checklist may apply to all firms. It is important for each item to be
evaluated with respect to the Lm hazards present in their operation. A ‘Notes’ section is included at the
end of each section to assist in collecting details about observations.

Part 1 of this checklist is for facilities that are producing product that is designed to have a kill step
before consumption. It includes basic Listeria control practices for all frozen vegetable operations to
consider implementing. Many of the elements implied by the questions are required by United States
regulations.

Part 2 is for facilities that are producing product that is not expected to have a kill step prior to
consumption. Firms should individually evaluate their market objectives when employing this section.
Many of the elements implied in these questions are consistent with current Food and Drug
Administration guidance for Lm in refrigerated or frozen ready-to-eat foods issued in 2008. This section
is designed to be used in addition to Part 1, thus the sections in this part do not contain basic control
strategies.

This checklist is intended as general guidance to assist facilities in developing Lm controls tailored to
their specific activities. It is not intended, nor should it be used, as legal advice. Facilities are
encouraged to seek independent regulatory counsel to ensure compliance with applicable
requirements.

This checklist does not include recommendations included in FDA’s January 13, 2017 draft Listeria
guidance for ready-to-eat foods. That guidance is currently subject to review by the Trump
administration. Revisions to this document based on the FDA draft guidance will be considered in a
later version.

Questions, comments, corrections?

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NWFPA would like to hear about from you so we can keep this document up to date.

Please contact staff with your feedback.

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Definitions
Food contact surfaces (FCS) – A surface in the post-lethality processing environment that comes in direct
contact with RTE product (9 CFR 430.1).

High-care area – An area designed to a high standard where practices relating to personnel, ingredients,
equipment, packaging, and environment aim to minimize product contamination by pathogenic
microorganisms.

High-care product – A product that requires chilling or freezing during storage, is vulnerable to the
growth of pathogens, received a process to reduce the microbiological contamination to safe levels
(typically 1-2 log reduction), and is ready to eat or heat.

Lethality step – A process that eliminates or reduces the number of pathogenic microorganisms on or in
a product to make the product safe for human consumption. Examples of lethality treatments are
cooking or the application of an antimicrobial agent or process, such as fermentation or drying, that
eliminates or reduces pathogenic microorganisms.

Preventive Controls Qualified Individual (PCQI) – A qualified individual who has successfully completed
training in the development and application of risk-based preventive controls at least equivalent to that
received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified
through job experience to develop and apply a food safety system (21 CFR 117.3).

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Part 1: Basic Listeria Control Strategies for Food Processing

This part includes internal audit questions designed to prompt analysis of Listeria control
strategies for operations producing frozen vegetable products that are expected to have an
additional lethality step prior to consumption. These questions reflect a combination of
industry best practices and current requirements under 21 CFR Part 117.

Sanitary Design of Facilities and Amenities

General
Has someone with expertise in sanitary design been an integral part of the facility/equipment
design team?
Has the PCQI or his/her designee signed off on the sanitary design of the facility and amenities?
Is sanitary design the top priority in facility/equipment design?
Is financing for the building/remodeling and equipping of the facility adequate to achieve the
desired level of food safety?

Grounds
Do the grounds have adequate drainage?
Are the grounds landscaped to prevent harborage of pests or contamination of air supplies
coming into the facility?

Facility
In the production areas, is there sufficient space provided to enable sanitary operation,
effective maintenance, and cleaning activities?
Are there adequate storage facilities for equipment, supplies, raw materials and other
ingredients, and product?
Is semi-finished food (vinegar, sugar syrup, oil, etc.) stored in outdoor bulk facilities adequately
protected from contamination by pests, dirt or other filth?
Is the roof designed and constructed so that it drains freely and does not leak?

Walls, Floors and Drainage, Ceilings

Are floors, walls, and ceilings of such construction as to be adequately cleanable and kept in
good repair?
Are floors of such material as to be smooth and non-porous to prevent harborage of Listeria?
Are floors and drains designed to facilitate good drainage and prevent standing water?

Traffic Patterns
Is the flow of product and people compartmentalized throughout, separating raw materials
from finished products?
Is the post-lethality environment isolated from the rest of the facility?

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Are traffic patterns for workers, management, visitors, consultants, etc. well defined to prevent
contamination of post-lethality product?
Are aisles or working spaces adequate to permit movement of workers, tools, and equipment
without potential for contamination?

Fixtures, Ducts, Plumbing, Lighting

Are fixtures, ducts, and pipes designed and installed in such a manner that drips or condensate
do not contaminate foods, raw materials, food-contact surfaces, or packaging materials?
Are air return ducts for HVAC or air makeup units accessible and capable of being cleaned and
inspected?
Is plumbing of adequate size and design and adequately installed and maintained to carry
adequate quantities of water to required locations throughout the plant?
Does the plumbing properly convey sewage and liquid disposable waste from the plant?
Is the plumbing designed so as not to constitute a source of contamination to food, water
supplies, equipment, or utensils or create an unsanitary condition?
Is there adequate floor drainage in all areas where floors are subject to flooding-type cleaning
or where normal operations release or discharge water or other liquid waste on the floor?
Does the plumbing provide that there is not backflow from, or cross-connection between,
piping systems that discharge waste water or sewage and piping systems that carry water for
food or food manufacturing?
Is sewage disposed of by means adequate to prevent contamination?
Are there adequate, readily accessible toilet facilities?
Are there hand-washing facilities designed to ensure that an employee's hands are not a source
of contamination of food, food-contact surfaces, or food-packaging materials?
Are all hand washing stations, lavatories, cafeterias, and locker room facilities properly designed
such that they can be cleaned and maintained in a sanitary manner?
Are rubbish and waste disposal systems designed such that rubbish and waste can be conveyed,
stored and disposed of so as not become an attractant for pests, or otherwise contribute to
contamination?
Is there adequate screening or other protection against entrance of pests into the facility?
Is there adequate lighting provided in all areas?
Is the lighting shatter proof and placed such that it doesn’t contribute to contamination?

Air Flow Quality and Patterns

Is there adequate temperature and humidity control to prevent condensate build-up and
growth of Listeria?
Is air flow and quality designed to prevent introduction or recirculation of Listeria into or
around the facility?

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 Construction, Plant Improvement, Maintenance Projects
During construction, plant improvements, and/or maintenance, is a food safety plan in place for
those special circumstances to prevent contamination?
Are physical and visual barriers present to separate the construction zone from food processing
areas and exposed product?
Is the pathway for debris removal contained to prevent contaminating other areas?
If food traffic is to be rerouted, are handwashing, gowning, and footbath stations in convenient
locations to support the temporary traffic flow?
Are contractors observing standard GMP requirements (hairnets, smocks, footwear, etc.)?
Is the post-construction plan for dust and debris removal, sanitation, etc. adequate to prevent
contamination of product when production resumes?
Has the post-construction sanitation been adequately verified by environmental monitoring
before resumption of production?
Has new equipment been adequately cleaned and verified to prevent contamination of
product?

Notes:

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Sanitary Design of Equipment & Utensils
General
Are equipment and utensils designed and of such material and workmanship as to be
adequately cleaned, inspected, and properly maintained to prevent contamination?
Are holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed,
and automated systems, of a design and construction that enables them to be maintained in an
appropriate clean and sanitary condition?
Do equipment and utensils meet design standards such as 3A Sanitary Standards Inc. (3A SSI),
European Hygienic Design Group (EHDG), or National Sanitation Foundation International (NSF)
or other recognized standards?
Is a sanitary design expert and/or qualified microbiologist consulted before purchasing and
installing equipment or utensils?
Has the PCQI or his/her designee signed off on the sanitary design of the equipment and
utensils?

Equipment and Infrastructure

Is equipment sufficiently raised over the floor to allow access for cleaning and water drainage
underneath?
Is equipment otherwise installed to facilitate cleaning and maintenance?
Where catwalks are necessary, are they enclosed and with adequate kick plates such that
surfaces beneath them won’t be contaminated with debris or water?
Is the framework of catwalks of solid construction so as not to accumulate water or debris?
Are instruments and controls used for measuring, regulating, or recording temperatures, pH,
acidity, water activity, or other conditions that control or prevent the growth of undesirable
microorganisms in food accurate, precise and adequately maintained, and adequate in number
for their designated uses?

Utensils
Are floor mats of adequate design so as not to become harborage sites for pathogens?
Are utensils and portable equipment color coded for differentiating use in raw versus processed
product areas?

Food Contact Surfaces

Are food contact surfaces made of non-toxic, corrosion-free material?
Are food contact surfaces designed to withstand the environment to which they will be
subjected?
Are seams on food-contact surfaces smoothly bonded and maintained to minimize
accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for
growth of microorganisms?
Are conveyors easily accessed for cleaning and inspection?
Are the rollers solid and without harborage points?
Do roller lubricants contain a listeriocidal agent?

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 Are compressed air or other gases mechanically introduced into food or used to clean food-
contact surfaces or equipment treated in such a way that food is not contaminated?
Are continuous use brines discarded or decontaminated sufficiently to control L.
monocytogenes?

Notes:

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Cleaning, Sanitation and Maintenance Practices
General
Is the overall sanitation of the plant under the supervision of one or more competent
individuals on all shifts?
Do you have comprehensive written procedures for pre-operative and operative sanitation?
Are sanitation procedures validated for effectiveness in removing Listeria?
Are all written procedures routinely monitored and documented on all shifts?
Where corrective actions/activities are needed, are these followed up on and documented?
Are quality control operations appropriate to verify monitoring and documenting on all shifts?
Is there adequate time between production runs for sanitation procedures to be accomplished
effectively enough to ensure adequate cleaning that prevents niches of Listeria from
establishing in the facility?

Pre-operative Sanitation
Is all extraneous material, such as food residues, dirt and soil removed from the facility prior to
cleaning?
Is the facility pre-rinsed and inspected for problem areas that may need more attention?
Is the facility adequately cleaned and sanitized as directed by one or more experts in food
facility sanitation?
Are effective chemicals or techniques used at the correct dilution, application time and
temperature, mechanical force, etc.?
Is high-pressure application of water avoided to prevent atomization of Lm?
Is the facility assessed for the effectiveness of the sanitation activities through an adequate
combination of inspection procedures, including routine microbiological and chemical testing,
such as ATP, as well as thorough visible examination?
Where problems are revealed through inspection, are these areas recleaned, sanitized and
reinspected prior to start-up?
Is excess water removed from equipment, floors, etc.?
If necessary, are food contact surfaces thoroughly dried before start-up?
Are floor drains cleaned adequately to prevent spread of Listeria?
Are tools dedicated and appropriately designed for this purpose only?
Are sanitation tools, supplies and equipment stored clean and dry in a sanitary location to
prevent Listeria growth?
Are sanitation supplies verified free from Listeria through letters of guarantee or certification,
and/or verified by suitable examination?
Is equipment that is newly installed or reinstalled after maintenance thoroughly disassembled,
cleaned and sanitized before installation?
Is freezing equipment thoroughly cleaned and sanitized frequently enough to prevent cross-
contamination with Listeria?
Are toilet facilities adequately cleaned before and during operation of the facility?

Operative Sanitation
Is the use of water for operational sanitation minimized, particularly with high-pressure hoses?

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Is the accumulation of standing water on equipment and floors prevented?
Are there appropriate operative sanitation controls to minimize or prevent the spread of
Listeria due to employee handling?
Are non-food-contact surfaces of equipment cleaned in a manner and as frequently as
necessary to protect against contamination of food, food-contact surfaces, and food-packaging
materials?
Are all food-contact surfaces cleaned and sanitized after any interruption during which the
food-contact surfaces may have become contaminated?
Where equipment and utensils are used in a continuous production operation, are they cleaned
and sanitized as necessary?
Are single-use articles stored, handled and disposed of in a manner that protects against
contamination?
Is food that has become contaminated rejected, stored and handled in a way that it does not
cross-contaminate other food?

Grounds
Are the grounds around the facility maintained in a manner that will prevent the possibility of
food adulteration from pests, air contamination, foot traffic into the facility, etc.?
Is litter and waste removed and weeds or grass kept cut down?
Are areas where water accumulates kept drained?
Are the areas around wet and/or dry waste or scrap compactors, modules, and dumpsters kept
clean and in good repair?
Are the roads, yards, and parking lots free from dust, standing water, or other potential
contaminants that could introduce contaminants into the facility?
Where sources of contamination occur on property not owned by the company, are adequate
measures taken to prevent pests, dirt, filth, etc. from becoming a source of food
contamination?

Maintenance
Is there an overall maintenance program that is designed to maintain buildings, fixtures, and
physical facilities in a clean and sanitary condition, and repaired adequately to prevent food
from becoming adulterated?
Is there regularly scheduled maintenance and cleaning of HVAC and air systems?
Is there a preventive maintenance program that catches and fixes corroded, cracked, or
damaged equipment or utensils?
Are maintenance and preventive maintenance programs monitored for compliance?
If there is an equipment “boneyard,” is it maintained sufficient to prevent contamination?
Are waste treatment and disposal systems operated in a manner to prevent contamination?

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Notes:

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Environmental Monitoring Considerations
Do management policies encourage environmental monitoring practices that seek to find and
eradicate transfer and harborage sites for Listeria in the facility?
Is there a written environmental monitoring plan?
Is the plan tailored to the facility, product and process?
Is the plan prepared by a PCQI with an objective to seek out transfer points and harborage sites
and destroy them?
Are there environmental monitoring procedures for verification of pre-operative sanitation
effectiveness, as well as operative procedures to verify protection against contamination during
food production?
Are good sampling procedures employed in the collection and handling of samples?
Is the plan directed toward detection of indicator organisms in the environment, such as Listeria
species?
When positive tests are found, is a root cause investigation conducted to find the source of the
problem?
Is the problem corrected and retested to verify correction?
Is the corrective action documented exactly as it occurred, no more or less?

Environmental Sample Collection and Handling

Are there science-based written procedures for collecting, handling and analyzing
environmental samples?
Are procedures followed in the collection of environmental samples?
Are samples properly handled prior to delivery to the laboratory?
Are samples properly stored prior to analysis?
Is sample analysis conducted and documented in a timely fashion?

Notes:

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Water Use in the Production Area
Water Supply
Is the water supply adequate for its intended use?
Is running water at a suitable temperature and under pressure, as needed, for processing of
food, for cleaning of equipment, utensils and food packaging materials, or for employee
sanitary facilities?
Do municipal water supplies meet EPA Standards for safe water?
If applicable, is an annual municipal water report maintained on file?
Is process water tested semiannually for potability?
If using well water, is it tested with sufficient frequency to ensure compliance with water
quality standards?

Water Control
Is reclaimed or recirculated water treated to eliminate Listeria?
Is the use of pressurized water in the production area limited or eliminated to prevent
atomization of Listeria?
Are handwashing facilities located away from production lines to prevent splashing onto
equipment?
Are floors and drains maintained to prevent standing water?

Notes:

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Good Manufacturing Practices and Personal Hygiene
Employee Training
Are all employees trained on GMP and personal hygiene procedures appropriate to their roles
and responsibilities?
Are training verification methods, such as testing, observation, etc., used to make sure
employees have learned and retained these trainings?
Are employees retrained with frequency adequate to maintain safe food handling practices?

Good Manufacturing Practices

Is traffic flow in the facility controlled to minimize movement of people from raw to finished
and in between without appropriate interventions?
Are raw materials cleaned and rendered suitable for processing into food and stored under
conditions that protect against contamination?
Are raw materials, rework and ingredients held in containers designed and constructed and at
temperature/humidity to protect against contamination?
Is rework identified as such?
Is rework and work in-process handled in a manner that protects against contamination and/or
growth of Listeria?
Where thawing is not necessary for use, are frozen vegetables and ingredients kept frozen?
For ingredients that support the growth of Listeria, are they held at temperatures that prevent
them from growing Listeria during manufacturing, processing, packing and holding?
Is finished product held in a manner to protect against contamination by raw materials, other
ingredients, refuse or other materials?
Is contaminated product disposed of in a manner that protects against contamination of other
food products?
If contaminated product is to be reconditioned, is a method used that has been proven to be
effective?
Is food transported and stored in a manner to protect against contamination?
Are transportation vehicles adequately equipped to control and monitor the
temperature of incoming ingredients and outgoing finished food products appropriately
to avoid the growth of Listeria?

Personal Hygiene
Do personnel working in direct contact with food, food contact surfaces and/or food packaging
materials maintain adequate personal cleanliness?
Do personnel wash their hands thoroughly in adequate facilities before starting work, after
breaks and at any other time when their hands may have become soiled?
Do personnel remove or cover jewelry which may result in contamination?
If appropriate to their job, are employees provided with clean, undamaged gloves, smocks,
aprons?
Are smocks or aprons color coded according to the areas where they work (e.g., to prevent
cross-contamination between raw and cooked products)?

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 When gloves are worn, are they maintained in an intact, clean and sanitary condition at all
times?
Are soiled clothes washed and not left around to create contaminated transfer points?
Is footwear worn by employees and visitors of such construction to allow effective cleaning?
Is such footwear cleaned sufficiently to prevent it from becoming a source of contamination in
the facility?
Are personnel instructed to report such conditions as illness, open lesions or other abnormal
sources of microbial contamination to their supervisor or appropriate management personnel?
Are any such personnel restricted from food handling operations or otherwise containing
sources of contamination, such as through the use finger cots or similar devices?
Where appropriate, are hair nets, beard covers and other hair restraints worn in an effective
manner?
Are activities such as eating, chewing gum, drinking beverages or using tobacco confined to
clean, designated non-processing areas of the facility?
Do personnel take any other necessary precautions to prevent contamination from things such
as perspiration, hair, cosmetics, tobacco, chemicals, and medications applied to the skin?
Where appropriate, are hair nets, beard covers and other hair restraints worn in an effective
manner?
Are activities such as eating, chewing gum, drinking beverages or using tobacco confined to
clean, designated non-processing areas of the facility?
Do personnel take any other necessary precautions to prevent contamination from things such
as perspiration, hair, cosmetics, tobacco, chemicals, and medications applied to the skin?

Notes:

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Part 2: Control Strategies for High Care Frozen Vegetable Operations

This part includes questions about Listeria control strategies for operations producing frozen
vegetable products that are not expected to have an additional lethality step prior to
consumption. This section is designed to be inclusive of Part 1 items.
Where appropriate guidance from FDA and others has been included in footnotes. However,
the references to ready-to-eat guidance is not meant to imply that following this checklist will
provide ready-to-eat product, nor are the references intended to conclude whether products
may be considered ready-to-eat or not ready-to-eat.

Sanitary Design of Facilities and Amenities

Facility Design
To reduce the potential for contamination of high care frozen vegetables via air,
aerosols, or traffic of employees or equipment, is the plant designed and constructed
to create effective physical barriers which separate post-lethality areas from areas
where raw foods are processed, exposed or stored, and from equipment washing
areas, microbiological laboratories, maintenance areas, waste areas, offices, and toilet
facilities?1
Is the plant designed and constructed so that walls, ceilings, windows, doors, floors,
drains, and overhead fixtures (e.g. pipes, air vents, and lights) in areas where high care
foods are processed or exposed are accessible for cleaning, resist deterioration by
product or cleaning chemicals, and prevent harborage of microorganisms? 2
Are construction materials which do not harbor microorganisms, used in areas where
high care foods are processed or exposed and in other wet processing areas in the
facility?
Are the appropriate controls in place to isolate microbiological laboratories from
processing areas and infrastructure (water, air supplies, etc.), preferably in another
building, and preventing contamination of products and processes?

Traffic Patterns
Is traffic restricted to the post-lethality area from other areas prior to the lethality
process? 3

1
FDA recommends that you provide separate locker areas, break areas, and cafeteria areas for employees who
handle RF-RTE foods and employees who handle raw foods.
2
FDA recommends that you not place windows that can be opened in areas where RF-RTE foods are processed or
exposed.
3 FDA recommends to, if possible, create separate entrances, worker facilities, etc. to prevent cross-contamination

by personnel and equipment entering the post-lethality area.

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 Is traffic to the post-lethality area restricted to appropriate personnel?
Are traffic flow patterns for people, food products, and equipment directed to
minimize the potential for transfer of L. monocytogenes between areas where raw
foods are processed or exposed and areas where high care foods are processed or
exposed?

Fixtures
Are appropriate foot sanitizing systems (wet or dry) used when entering areas where
high care foods are processed or exposed?4
If non-automatic foot sanitizing systems are used, are they checked at regular
intervals, such as hourly, to ensure that they are filled with sanitizer, that the sanitizer
is diluted to the proper concentration, and that the spray pattern, if applicable, is
sufficient to be effective?

Air Flow Quality and Patterns

In designing the air flow in your plant, is positive air pressure maintained on the high
care side of the operation relative to the "raw" side (i.e., maintain higher air pressures
in high care areas and lower air pressures, even negative pressure, in raw areas)? 5
To avoid contamination of intake air, is the location of the air intake removed from the
location of the air exhaust or other sources of airborne contamination such as waste
disposal areas? 6
Is the air filtered to the appropriate particle size?
Is there appropriate air pressure in specific zones of the plant, e.g., negative in raw material,
positive in post-lethality? 7

4
An example of a footbath is an automatic spray of foam disinfectant on the floor where people and equipment
(such as carts and forklifts) enter the high care area. A footbath may also be a low flat container or a water tight
recess in the floor with a non-slip surface and filled with a suitable sanitizer.
5
FDA recommends that you consult individuals with appropriate engineering skills to determine how to achieve
proper air balance, including determining the number, size, and location of intake and exhaust fans. Appendix 1 of
FDA’s 2008 Listeria guidance document provides some schematic diagrams relevant to these recommendations.
6
To reduce the potential for contamination of foods with microorganisms (including L. monocytogenes), FDA
recommends that you design and construct the plant so that the air in rooms where refrigerated or frozen ready-
to-eat (RF-RTE) foods are processed or exposed will be filtered. To remove bacteria (including L. monocytogenes)
as well as yeasts and molds, FDA recommends that you filter the air in areas where RF-RTE foods are processed or
exposed through High Efficiency Particle Air (HEPA) filters that have an efficiency of 99.97-99.99 percent at 0.3
micron. If you are not able to use such filters, they recommend that the final filter have an efficiency of at least 90-
95 percent at 1 micron as rated in ASHRAE standard 52.2-1999. This recommendation to filter air is particularly
important when major construction or remodeling occurs in an existing plant, because using air-tight barriers and
limiting access between construction and food production areas can prevent introduction of contamination into
the plant environment.
7
FDA recommends that you dry and filter compressed gases or air used directly in or on RF-RTE food, or on RTE
food-contact surfaces. They recommend that dehydration be done at the source of gas or air supply and that
filtration be done at the point of use, using a filter that can retain particles larger than 0.3 micron. You should take
appropriate steps to maintain the filters.

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Notes:

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Sanitary Design of Equipment and Utensils
Equipment and Infrastructure
Is equipment that you purchase and use to process high care foods designed and
constructed to facilitate cleaning and to minimize sites where microbial harborage and
multiplication can occur?
Has a person qualified in sanitary design of food processing equipment reviewed the
design of equipment to be installed, regardless of whether the equipment is new or
existing, including existing equipment that is being modified?
Are food-contact surfaces smooth, non-absorbent, sealed, easily cleanable, sloped to
drain freely, and made of durable, non-corrosive and non-toxic materials?
Are control panels designed and sealed to prevent harborage of pathogens?
Are bolts, studs, mounting plates, brackets, junction boxes, name plates, end caps,
sleeves and other such items continuously welded to the surface of the equipment?
Are welds and other connections smoothly bonded (e.g., free of pits, folds, cracks,
crevices, open seams, cotter pins, exposed threads and piano hinges) with junctures
that are covered?
Are hollow areas of equipment (e.g., frames, rollers) eliminated, where possible, or
permanently sealed, if not?
Is piping used to convey high care foods free of dead ends or cross-connections
between raw and high care foods?
Is equipment, such as catwalk framework, table legs, conveyor rollers, and racks,
designed and constructed so that they cannot collect water that could harbor L.
monocytogenes (e.g. not hollow or foam filled)?
Do ladders and stairs in areas where high care foods are processed or exposed have
plating underneath that prevents any debris from shoes or other items from personnel
who are using them from falling onto the processing line?
Do these plates have up-turned edges so that debris that falls onto the plates cannot
roll off and onto the lines?
Are catwalks and stairs with open grating positioned such that they are not over
exposed high care food or food-contact surfaces.
Is stationary equipment used to process high care foods installed such that it is not
over floor drains that could splash and contaminate the food?
Are food contact surfaces of stationary equipment (including conveyors) used to
process high care foods sufficiently elevate above the floor to prevent contamination
by floor splash?
If overhead conveyors cannot be avoided, are they designed to be easily accessible for
cleaning? 8

8
When possible, FDA recommends you avoid overhead conveyors.

Page 23 of 44
 Utensils
Are only pallets that can easily be cleaned and kept in good condition used in high care
areas? 9
Are equipment and utensils that are uniquely color coded for the high care area used
in the high care area only? 10,11
Are the wheels of racks used for transporting exposed high care foods covered with
cleanable guards over them to prevent contaminations of high care foods and food
contact surfaces from wheel spray?
Are listeriocidal substances (e.g., sodium benzoate) added to lubricants (e.g., chain,
valve, and seal lubricants) so that the lubricants do not become contaminated with
product residue and, thus, become a niche for L. monocytogenes?
Are tools intended for maintenance of equipment used in areas where high care foods
are processed or exposed dedicated to those areas?
Are wipes disposable and discarded after each use on high care food-contact surfaces?

Notes:

9
FDA recommends that you do not use wood pallets in areas where RF-RTE foods are processed or exposed or in
other areas for wet processing and storage.
10
FDA recommends that you designate one set of equipment such as carts, forklifts, mobile racks, and pallets to
areas where raw foods are processed or exposed and designate a separate set of such equipment to areas where
RF-RTE foods are processed or exposed.
11
FDA recommends, with respect to containers:
• Distinguish between containers used for product, rework, or waste;
• Clearly label containers;
• Select containers that can easily be cleaned;
• Dedicate containers by function (e.g., in-process products, rework and waste);
• Dedicate containers by area (e.g., use one set of containers in areas where RF-RTE foods are processed or
exposed and a different set of containers in areas where raw foods are processed or exposed); and
• Use a mechanism such as color-coding to identify containers by function and area.

Page 24 of 44
Cleaning and Sanitation Practices
General
Is there a written sanitation program established and in use that includes a sanitation
standard operating procedure (SSOP) and a sanitation maintenance schedule for areas
where high care foods or food-contact surfaces are processed or exposed?12
Is the sanitation program or an equivalent reference readily available to personnel who
are responsible for cleaning?
Are sanitation procedures monitored for adherence to the sanitation program?
Are corrections or corrective actions applied and documented appropriately?

Pre-operative Sanitation
Do cleaning and sanitizing equipment generally include the following steps:
o Removal of heavy soil or debris from equipment, if needed;
o Pre-rinsing the equipment;
o Foaming and scrubbing the equipment with an effective cleaner;
o Rinsing the equipment after treating it with the cleaner;
o Sanitizing equipment 13; and
o Visual inspection of food-contact surfaces for residues of cleaning
agents or sanitizing agents? 14,15
Do cleaning and sanitizing floors include the following steps:
o Removal of heavy soil or debris from floors (e.g., with brooms or
shovels), if needed;
o Cleaning other debris from floors;
o Rinsing floors with water using a low pressure/low volume hose;

12
FDA provides recommendations for schedules for routine cleaning and sanitation in Appendix 2 of their 2008
Listeria guidance document.
13 Sanitizers containing quaternary ammonium compounds (QACs), peroxyacetic acid, iodine, or chlorine have

been used to control L. monocytogenes in various situations. FDA recommends the use of QACs for many
applications, because QACs have been found to be effective against L. monocytogenes and leave a residual
germicidal effect on surfaces. FDA notes that peroxyacetic acid sanitizers have been shown to be effective against
biofilms containing L. monocytogenes. FDA recommends that you rotate sanitizers, because this has been reported
to provide for greater effectiveness. Hot water, steam and ClO2 gas have been successfully used to sanitize racks
and equipment that is difficult to clean. Ongoing research in this area is yielding new sanitizing tools and products
and processors should keep abreast of these developments for potential solutions to their Listeria control
challenges.
14
For clean-in-place (CIP) systems, FDA recommends that you monitor the concentration of cleaning solutions and
sanitizers and verify flow rate, duration of the cleaning cycle and temperature. For clean-out-of-place (COP)
systems, they recommend that you monitor the concentration of cleaning solutions and sanitizers.
When using CIP systems, FDA recommends that you dedicate separate CIP systems for cleaning equipment used to
process RF-RTE food and for cleaning equipment used to process raw food. If you are unable to designate separate
CIP systems and, thus, use a common CIP system, they recommend that you maintain the temperature of an
alkaline cleaning solution at or above 71 degrees C (160 degrees F).
15
When using COP systems (e.g., wash tanks), FDA recommends that you dedicate separate COP systems for
cleaning equipment used to process RF-RTE food and for cleaning equipment used to process raw food.

Page 25 of 44
 o Using a dedicated brush or floor scrubber to scrub floors with an
effective cleaner, applying water as needed;
o Thoroughly rinsing floors using a low pressure/low volume hose;
o Sanitizing floors; and
o Removing excess water from floors if needed. Floor scrubbing
implements should not be used to clean product contact surfaces?
Are sanitation control records established and maintained that document:
o Your sanitation monitoring; and
o Corrections or corrective actions of monitored sanitation conditions and
practices that are not implemented in accordance with your sanitation
program?
Are pallets and wheels of transport equipment (e.g., carts, forklifts, and mobile racks)
cleaned and sanitized before they enter an area where high care foods are processed
or exposed?
Are filters used on intake air examined and changed either at a frequency based on the
manufacturer's specification or more frequently based on pressure differential or the
results of environmental monitoring?
Are equipment and tools in food contact areas maintained such that they do not
become a source of contamination? 16
Are equipment and food-contact surfaces used in areas where high care foods are
processed or exposed cleaned and sanitized after maintenance and prior to use in
production? 17
Is equipment that could become contaminated as a result of maintenance on facility
utilities (e.g., air or water systems) or remodeling cleaned and sanitized prior to use?
When assembling cleaned and sanitized equipment (e.g., pump impellers, pipes), are
equipment parts placed on clean surfaces and kept off the floor?
Is water from the floor or unclean equipment prevented for splashing onto the clean
equipment?
Is equipment used for cleaning (e.g., hoses, ladders, gear, brushes, mops, floor
scrubbers, and vacuum cleaners, etc.) maintained and cleaned so that it does not
become a source of contamination? 18
When scouring pads are not in use during the day, are they kept dry or placed in a
sanitizer solution?19
Are evaporation drain hoses properly cleaned, sanitized and monitored?

16
Examples where such equipment may become sources of contamination include chipped, cracked, broken
and/or scratched items. The rough surfaces that are difficult to clean can harbor pathogen niches that get
deposited on food. Temporary fixes such as taping, spot welding, etc. can create sources of contamination, too.
17
FDA recommends that the areas for washing equipment that contacts RF-RTE foods be located in a room that is
separate both from areas where RF-RTE foods are processed or exposed and from areas where equipment that
contacts raw foods are washed.
18
FDA recommends that you dedicate cleaning equipment either to areas where RF-RTE foods are processed or
exposed, or to areas where raw foods are processed or exposed, using a mechanism (such as color coding) that
easily distinguishes the equipment dedicated to the two areas.
19
FDA recommends disposing of scouring pads after each use.

Page 26 of 44
 Operative Sanitation
Are sanitation conditions and practices during processing monitored with sufficient
frequency to ensure the cleanliness of food-contact surfaces and prevent cross-
contamination?
Are sanitation conditions, cleanliness and practices that are not implemented in
accordance with the sanitation program corrected in a timely manner?
Is use of pressurized water avoided during production in high care areas?
Are sinks or washing areas located away from product or product contact surfaces to
prevent splashing Listeria-contaminated water?

Notes:

Page 27 of 44
Environmental Monitoring Considerations
The Environmental Monitoring Plan
Is a written plan for the collection of environmental samples from critical surfaces and
areas established and implemented, and for testing those samples for the presence of
Listeria species or L. monocytogenes? 20
Does the plan evaluate each plant, product, and process to determine the appropriate
monitoring points?21
Does the plan include plant blueprints with designation of zoned areas?
Does the plan include sample collection during pre-operative inspection, as well as key
operational times? 22
Does the plan include instruction for increased intensity of sampling for planned
events (construction, major repairs, equipment installation, etc.)?
Does the plan include instructions for responding to unplanned events (water leaks,
major hygienic zones breach, fires, etc.)? 23
Does the plan use screening tests for the presence of Listeria species to more rapidly
identify harborage sites?24
Does the plan include directions for corrective actions or preventive measures when a
positive sample is found?
Does the plan include instructions for documentation of sample collection, handling
and results?
Are results reviewed for trends that could indicate developing problems before
product becomes implicated?

Sample Collection
Are samples collected and handled according to established industry procedures? 25
Are samples tested using recognized methodology?

20
For critical food-contact surfaces, FDA recommends that your written plan include collection and testing
environmental samples from all, or representative sets of, such surfaces at least once every week. If you will test a
representative set of samples (rather than all samples) each week, they recommend that your plan for sample
collection and testing be designed so that all critical food-contact surfaces are tested at least once each month.
They suggest that the most important time to collect these environmental samples is at a time that is both prior to
cleanup and no sooner than the middle of production.
On the other hand, the American Frozen Food Institute recommends testing food contact surfaces only when
environmental monitoring suggests there may be a problem in the facility. For critical non-food-contact surfaces
and areas, FDA recommends that your written plan include collection and testing of environmental samples from
all, or representative sets of, such surfaces and areas at least once every two weeks.
21
The Grocery Manufacturers of America (GMA) recommends focusing on the sampling of interfaces, transition
areas or barriers between raw areas and at-risk product areas to verify the effectiveness of preventive controls at
maintaining separation. See their environmental monitoring guidance for examples of sample sites.
22
GMA recommends sampling Zones 1-3 no sooner than three hours after the beginning of production.
23
See GMA environmental monitoring guidance for strategies in dealing with planned and unplanned events.
24
These tests usually are more rapid than tests for L. monocytogenes allow harborage niches to be identified more
rapidly.
25
See GMA environmental monitoring guidance, as well as the Compendium of Methods for the Microbiological
Examination of Foods.

Page 28 of 44
 Is the sample size representative of the process and the plant history of control?26
If you test a representative set of samples (rather than all samples) each time, is the
plan for sample collection and testing designed so that all critical non-food-contact
surfaces are tested at least once each quarter? 27
Are the sample sites selected with the goal of finding transfer and harborage sites for
Listeria, including high traffic areas and/or high moisture sites? 28
Are the sites of sample collection varied on a rotating basis, particularly where there
are predominantly negative results? 29
When food contact surfaces are sampled during a pre-operative inspection, is the
equipment cleaned and sanitized again prior to beginning production?
Are results reviewed in a timely fashion, such that any positive result is responded to
as soon as possible?
Are results reviewed for trends that could indicate developing problems before
product becomes implicated?
When testing on Zone 1 surfaces, are appropriate procedures in place to prevent
distribution of product into commerce?

For Cause Investigation

Is the investigation initiated as soon as possible after screening tests indicate positive results
without waiting for confirmation of Listeria monocytogenes?
When positive Listeria species are found, is an analysis done to determine if the site is
a transfer point or harborage site?30

26
See the USDA Introduction to the Microbiology of Food Processing for a discussion of sample size and frequency.
27
The number of samples that you should collect depends on the size of your production lines. FDA recommends
that even the smallest processors collect samples from a minimum of 5 sites in each area where RF-RTE foods are
processed, exposed, or stored. They recommend that larger processors determine the appropriate number of
sampling sites based on the size of the facility.
28
If you detect contamination of a critical food-contact surface or food with Listeria species, FDA recommends that
you either conduct a test to determine whether the Listeria species is L. monocytogenes, or assume that the
Listeria species is L. monocytogenes.
29
For examples of sites to sample, see the sites that FDA identifies as potential sources of contamination with L.
monocytogenes in sections D and E of Table 1 in the 2008 FDA Listeria guidance document.
30
Dr. John Butts writes in his 2003 Food Safety Magazine article, introducing the concept of Seek & Destroy, that
there are two modes of product contamination with Listeria monocytogenes. “The first is product contamination
via transfer point, which is a Good Manufacturing Practices (GMP)-controlled event. The second is product
contamination via growth niche.” Because the latter may involve much larger quantities of product, elimination
and management of growth niches should be the priority to focus in high care areas.
Dr. Butts observes that factors that give rise to the development of growth niches include:
• Equipment design problems,
• Certain operational conditions such as product debris working its way into an uncleanable location,
• Mid-shift cleanup,
• Use of high pressure during cleaning, and
• Existing product characteristics that require excessive rinsing such as those encountered when producing
sticky products.
See GMA environmental monitoring guidance for strategies to investigate positive test results.

Page 29 of 44
 If the positive sample is determined to have come from a harborage site (or growth
niche), has an analysis been done that reveals the root cause of the contamination? 31
Where a positive test result is found in Zone 1, is finished product evaluated for
contamination? 32

Not For Cause Investigation

Is environmental monitoring used to validate levels of disassembly for normal and
periodic enhanced sanitation procedures?
Is new equipment, equipment brought from storage, or equipment new to a high care
area evaluated for an effective pre-operative sanitation procedure at installation and
at appropriate intervals for up to 90 days after installation? 33
Is environmental monitoring used to measure the effectiveness of hurdles and barriers
in the process?

Notes:

31
See Footnote #27.
32
See GMA environmental monitoring guidance for strategies to investigate Zone 1 positive test results.
33
Investigate for a harborage site on a piece of equipment by
1. Observe and evaluate that normal cleaning and sanitation steps have been conducted according to the
sanitation plan;
2. Disassemble the equipment back to its normal level of disassembly as specified in the sanitation plan,
looking for any questionable areas and swabbing them for microbial activity;
3. Continue to completely disassemble the equipment, looking for questionable areas and swabbing
accordingly. If unacceptable levels of organic buildup are found during this extended disassembly process,
evaluate if the degree of normal disassembly is acceptable, or if the normal cleaning methods are
inadequate.
See Malley et al 2015 article if further investigation of transfer pathways or transient equipment is called for.

Page 30 of 44
Water Control in the Production Area
Are water treatment systems maintained and inspected to ensure that they do not
become a source of microbial contamination?
Are ice and ice utensils handled and stored in a manner that protects ice from
microbial contamination?
Do employees refrain from using high-pressure water hoses in areas where high care
foods are processed or exposed during production or after equipment has been
cleaned and sanitized?
In a high care room where wet cleaning of equipment (e.g., down lines, storage and
spiral coolers, and spiral freezers) is allowed, is the risk of aerosolization controlled
where high care food is exposed?
If wet cleaning is allowed, is all exposed high care food removed from the room before
beginning any wet cleaning of equipment, floors, etc.?
If wet cleaning is allowed, is the process monitored and verified that contamination is
adequately prevented?
Is all exposed high care food removed from a cooler prior to cleaning the cooler,
refrigeration condenser units or condensate drip pans and hoses?
Are hose nozzles kept off the floor or other unclean surfaces in high care areas? 34
Are floor drains cleaned and sanitized in a manner that prevents contamination of
other surfaces in the room? 35
Are water systems adequately designed, installed, and maintained to prevent backflow
and cross-connections between potable and non-potable water lines or systems?
Are back flow devices installed in drains to prevent water backing up into an area
where high care foods are being processed or exposed?
If a drain backs up and water flows into an area where high care foods are being
processed or exposed, are steps taken to avoid splashing any equipment and the
following sequence of steps taken to clear the drain and clean the area around it:
• Stop any production;
• Remove any uncovered high care foods from the affected area and isolate for
further review;
• Clean and sanitize the area per the written sanitation program?

34
For example, you could install and use automatically retractable hoses (including spring tension or spring loaded
retractable hoses) or fixed length hoses that do not touch the floor.
35
To do so, the FDA and industry experts recommendation that:
• You not clean floor drains during times when high care foods are processed or exposed;
• You not use high-pressure hoses to clear or clean a drain, because use of such hoses could create aerosols
that may spread contamination throughout the room;
• Brushes used to clean floor drains be at least ¼ inch (0.64 cm) smaller than the diameter of the drain
opening;
• You use a splashguard to prevent splashing during cleaning;
• Utensils that you use for cleaning drains be dedicated to that purpose and be easily distinguishable from
utensils used for other purposes (e.g., by color-coding).

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 Do employees change clothes and wash and sanitize hands before touching a high care
food-contact surface after cleaning a drain?
Do you use bactericidal drain treatments in high care areas?
Are drain rings monitored and replaced when appropriate to maintain bactericidal
properties?
Are steps taken to prevent the accumulation of standing water in and around drains?36
Is condensate managed in a manner to prevent it from contacting exposed high care
foods, food-contact surfaces, and food packaging material? 37
Is condensate from refrigeration evaporation coils directed to a drain through a hose
or, alternatively, collected in a pan that drains through a hose or suitable pipe to a
drain?38

Notes:

36
To prevent the accumulation of standing water in or around drains, recommendations are:
• You design and construct the plant in a way that will make drains adequately accessible for cleaning and
function;
• You eliminate trench drains in areas where RF-RTE foods are processed or exposed and replace them with
enclosed plumbing to a floor drain; when this is not possible, we recommend that you equip trench drains
for automatic flushing;
• You design and construct drains so that the drains conform to applicable plumbing codes and do not flow
from areas where raw foods are processed or exposed to areas where RF-RTE foods are processed or
exposed;
• You design and construct drains so that restroom drains are downstream of drains serving areas where
RF-RTE foods are processed or exposed;
• The slope of floors to drains be at least 0.25 inch per foot (0.64 cm per 30.5 cm); and
• Sewer lines not be located above areas where RF-RTE foods, food-contact surfaces, or food packaging
materials are processed or exposed. If this is not possible, take steps to protect RF-RTE foods from
potential leakage, e.g., by shielding the sewer lines to prevent or convey leakage.
37
Measures that can help prevent the formation of condensate include exhausting vapors from cooking
operations, using dehumidifiers, and providing adequate ventilation.
38
An air gap or other back flow mechanism should be in the drain line to prevent back flow from the sewer system
to the drip pan. Regularly inspect the pan and drain to ensure that the hose or pipe does not become clogged.

Page 32 of 44
Good Manufacturing Practices and Personal Hygiene
Is there an adequate, risk-based supply chain program in place?
Is it being monitored and documented?

Personal Hygiene
Is health and hygienic practices training provided for all employees, contractors and
visitors who enter high care production and storage areas (e.g., employees who
conduct production, maintenance, quality assurance, quality control, or warehousing
operations), including employees and contractors who are temporary or seasonal? 39
Are all persons who enter an area where high care foods are processed or exposed
required to thoroughly wash their hands before doing so?40
When gloves are used, do:
• Employees wash their hands before putting the gloves on;
• Multi-use gloves get washed and sanitized after the employee touches any
non-food-contact surface;
• Single use gloves get discarded and replaced after the employee touches
any non-food-contact surface; and
• Gloves that are worn outside areas where high care foods are processed or
exposed (e.g., restrooms) get discarded before returning to the high care
area?
Are appropriate policies in place with respect to clothing worn in high care areas? 41
Are gloves and footwear worn by employees who handle high care foods or who work
in areas where high care foods are processed or exposed in good repair, easily
cleanable or disposable, and managed appropriately to prevent contamination?
Is the use of cleated footwear excluded from high care areas, unless it is necessary for
employee safety?

39
Training should be designed with special consideration of the high care environment and conducted before the
employee performs job activities with refresher training on an annual basis.
40
FDA also recommends that employees use suitable utensils (such as spatulas or tongs), or wear gloves, when
touching exposed RF-RTE foods, food-contact surfaces, and packaging materials, and not touch exposed RF-RTE
foods, food-contact surfaces, and packaging with bare hands.
41
With respect to clothing, do:
• Personnel not wear street clothes in areas where high care foods are processed or exposed unless the
street clothes are adequately covered above the knees (e.g., with a clean smock);
• Smocks in areas where high care foods are processed or exposed get worn only in the high care area
and an adjacent vestibule (i.e., the area where the smock would be put on);
• Smocks get laundered or disposed of daily or more often as necessary to prevent contamination;
• Personnel change into a clean uniform or smock before entering areas where high care foods are
processed or exposed;
• Smocks or uniforms that will be used in areas where high care foods are processed or exposed get
distinguished from smocks or uniforms that will be used in other areas (particularly areas where raw
foods are processed or exposed) using a mechanism such as color coding; and
• Smocks or uniforms get distinguished according to the task that the employees perform (e.g.,
production or maintenance).

Page 33 of 44
 Do maintenance personnel, management personnel, contractors, and visitors in areas
where high care foods are processed or exposed comply with the same hygiene
requirements as production employees in those areas?
Are mixed hot and cold water available at hand washing stations?

Good Manufacturing Practices

Are continuous use brines and recycled process water used in direct contact with high
care foods discarded or decontaminated with sufficient frequency to control L.
monocytogenes? 42
Are procedures established and implemented to minimize the amount of time that
ingredients and other raw materials, in-process materials, and finished foods are
stored?
Are transportation vehicles inspected for structural integrity, cleanliness, and overall
suitability when unloading ingredients and prior to loading finished products?

Notes:

42
To decontaminate such brines and water, use measures such as chlorination, heat treatment, or other effective
treatment. In determining the frequency of decontamination treatment, you should consider the results of
environmental monitoring for L. monocytogenes.

Page 34 of 44
Appendix I. Sample Swab Test Procedure

This procedure represents an example of one company’s approach to swab testing. It is for illustration
purposes only and the Northwest Food Processors Association does not endorse or recommend that
companies follow this procedure.

Procedure – Environmental and Food Contact Surface Swabbing (sponge) for Pathogen Surveillance

PURPOSE
Define the procedure for collecting sponge samples to be used for pathogen surveillance.

ASSOCIATED STANDARDS AND REFERENCES

Compendium of Methods for the Microbiological Examination of Foods, Third Edition, 1992.
3M™ Sponge-Stick Product Instructions 2013-03

PROCEDURE

Materials Required for Test:

o Labeling supplies. Pressure sensitive tapes and labels, tags of adequate size to hold sample
information, indelible marking pens
o Nitrile gloves or sterile plastic gloves
o Sterile cellulose sponges hydrated with neutralizing buffer
 3M™ Sponge-Stick - preferred
 3M™ Hydrated-Sponge

Swabbing with sponge:

o Label sampling sponge bags with sample site, date and time.
o One sponge is needed for each pathogen tested at each sample site. For example, if the site is
tested for Listeria and Salmonella, two sponges are required for the sample site.
o Hands should be washed before sampling commences. The collector should keep their hands
away from the mouth, nose, eyes and face during collection. Hand washing should also take
place if hands become contaminated.
o To reduce the risk of cross contamination:
 Do not touch the sponge or sponge stick to any unintended surface.
 Do not break the sponge from the stick while sampling.
 Do not reach into the sponge bag.
 Do not use the same sponge-stick more than once.

Page 35 of 44
 o At the sampling site, remove the sponge from the bag with sterile gloves:
 Push the stick or sponge to the top of the bag.
 Tear the sterile gloves from the sampling bag
 Open the sponge bag horizontally by pulling on the tabs on each side.
 Remove the sterile gloves from the bag taking care to touch only the wrist area of the
glove.
 Remove the sponge-stick or sponge from the bag with the sterile gloves
o Using moderate downward pressure, rub the sponge over a 1 square foot (12 in. X 12 in.) area.
Swab the area in two directions, flipping the sponge over for the second direction. For sample
sites less than 1 square foot (12 in. X12 in.), the entire surface should be sampled. See Figure 1
for an example of an adequate swab pattern. If swabbing for multiple pathogens, adjacent
areas should be swabbed.
o Return the sponge to the sample bag and transport to the laboratory for testing. Bend the stick
to separate it from the sponge. Discard the stick, do not return it to the bag. Roll the top of the
bag down and fold in the blue side tabs. Sponges must be tested within 36 hours of collection
and kept refrigerated until testing commences.
Figure 1 - Properly swabbed area

Figure 2 - Inadequate swab pattern

Page 36 of 44
Appendix II. Sample Environmental Foodborne Pathogen Surveillance

This procedure represents an example of one company’s approach to environmental foodborne

pathogen surveillance. It is for illustration purposes only and the Northwest Food Processors Association
does not endorse or recommend that companies follow this procedure.

Environmental testing is used to:

• Establish a baseline for determining when the facility’s environment is considered under
control
• Investigate a source of environmental contamination so corrective actions can be
implemented.
• Verify that prerequisite programs (including GMPs) are helping control the risk of
product contamination.

DEFINITIONS
Pathogen: For this procedure, any of the tested organisms listed below.
Listeria: Genus of ubiquitous gram-positive rods found in association with a wide variety of
fish, birds, mammals, and plant material. Several species are contained in the Genus, one of
which is a foodborne pathogen (L. monocytogenes). Listeria spp. refers to all without
designating a specific species.
Salmonella: Genus of gram-negative non-sporeforming rods that grow over a wide range of
temperature, pH, and water activity. The better the food source for the bacterium, the
wider the range of growth. People and animals are directly or indirectly the source of
contamination from Salmonella. Meats and dairy products have traditionally been common
foodborne sources of Salmonella, but recently outbreaks have involved fruits and
vegetables.
Escherichia coli O157:H7 - E. coli serotype O157:H7 is a variety of E. coli that produces large
quantities of one or more related, potent toxins that cause severe damage to the lining of
the intestine. Most of the confirmed E.coli O157:H7 cases have been linked to undercooked
ground beef. Other sources of the bacteria have included raw milk, unpasteurized apple
cider, fresh produce, and fresh sprouts.
ASSOCIATED STANDARDS AND REFERENCES
• “Microorganisms in Foods 7 Microbiological Testing in Food Safety Management”, 2002.
• Control of Listeria monocytogenes in the Food-Processing Environment. R. B. Tompkin.
Journal of Food Protection, Vol. 65, No. 4, 2002, Pages 709-725.

PROCEDURE
• Environmental Monitoring:
o Each factory will develop a specific plan for sampling representative points
throughout the facility.

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o The sample plan shall define the sampling points and assign an identification
number to each sample point within each zone.
o The plant is divided into four zones. These are defined as follows:
 Zone 1: Food contact surfaces (FCS) following the last lethal heat treatment.
Sample points within Zone 1 include:
Conveyors, tables, racks, holding vats and tanks, utensils, pumps, valves,
freezers, filling/packaging machines. Identify areas where product builds up
during processing. These areas may have a higher risk for biofilms and
harborage.
 Zone 2: Non-food contact surfaces in close proximity to food product following
the last lethal heat treatment.
Sample points within Zone 2 include:
Exterior of equipment, refrigeration units, drip pans, floors. Emphasize precool
areas and cold packaging areas.
 Zone 3: Areas or items which are less likely to lead to product contamination,
but which may hinder efforts to control pathogens and from which pathogens
could potentially be transferred to zones 1 or 2. Sampling sites in zone 3 include:
All processing areas prior to the last lethal heat treatment; floors, telephones,
forklifts, walls, drains.
 Zone 4: Areas outside of the processing area that might contribute to
contamination due to traffic flow if not maintained at an acceptable level of
cleanliness.
Sample points within Zone 4 include:
Raw receiving areas within the processing facility proper, employee cafeterias or
break areas, locker rooms, hallways, Q.A. laboratories (the microbiology lab will
fall under the microbiology environmental plan but is still zone 4), dry
warehouse, especially where forklift traffic goes to packaging, and any other
areas within the processing facility proper, but not in the processing/packaging
room.
o Sampling Plan: Identify sampling sites for each of the 4 zones. Sampling locations
are selected according to the potential risk of product contamination.
 Random sampling of specific site locations will be performed weekly by utilizing
a random sample selector. However, all sites on the list shall be tested at least
once during a twelve-month period.
o Sampling Frequency:
 Zone 1: Two samples taken weekly per line for Listeria spp.
 Zone 2:
Six samples taken weekly per line for both Listeria spp. and Salmonella spp.
Six samples taken monthly for E. coli O157

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  Zone 3:
Three samples taken weekly per line for both Listeria spp. and Salmonella spp.
Three samples taken monthly for E. coli O157
 Zone 4:
Two samples taken weekly for both Listeria spp. and Salmonella spp.
One sample taken monthly for E. coli O157
Raw product receipt within a facility and traffic routes from this area should be
evaluated for a higher frequency of sampling.
 Environmental sponges must be tested as individual samples. No composite
testing is allowed.
 Test samples for Listeria spp., Salmonella spp. and E. coli O157 using validated
methods for environmental samples.
 Confirmation for Listeria monocytogenes will not be performed on any sample
testing presumptive positive for Listeria spp.
 Samples testing presumptive positive for Salmonella or E. coli O157 are to be
confirmed.
o Corrective Action if an environmental foodborne pathogen is found:
 Zone 1:
• Intensified cleaning and sanitizing of the area. Document actions in a
corrective action log.
• Retest the same positive food contact surface (FCS) along with 2-3 adjacent
sites after cleaning but prior to sanitizing. Include the positive site in the
next two weekly sample sets.
• Adjacent sites should target the most likely source of contamination.
• If the retest of the site (with adjacent sites) tests negative three consecutive
times for the environmental pathogen corrective action appears to have
resolved the problem. Note negative results in the Corrective Action Log
comments for the positive sample. Resume normal schedule for FCS testing.
• If any of the follow-up samples are positive, initiate a GMP investigation and
detail the findings of the investigation. Repeat intensified cleaning, follow-up
testing and sanitizing.
• If a third FCS sample for the site tests positive, facility management will
convene a meeting to perform an assessment. The investigation will try to
determine the cause and source of the contamination. This will include a
review of the sanitation and process flow to determine if there are design or
execution flaws. Other remedial actions may include improved GMP’s and
employee re-training

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 Zones 2-4:
• Intensified cleaning and sanitizing must be completed during the next
scheduled clean-up. This is documented in the corrective action log.
• Retest the same positive site along with 3-5 adjacent sites during the next
weekly set following documented corrective action.
Adjacent samples are used to aid in the investigation of the cause of a
positive environmental pathogen sample in the area.
o If negative, continue weekly testing of the original site until three
consecutive follow-up samples test negative.
o Whenever three consecutive follow-up samples test negative, resume the
normal schedule of testing, as the corrective action appears to have
resolved the issue.
• If the repeat sample is positive for the environmental pathogen take
immediate corrective action, which will include:
o Review of the cleaning activity following the original positive result.
o Documented intensified cleaning and sanitizing, adjusting the activity
based upon the review.
o Sample additional sites in the surrounding area (3-5 adjacent samples),
targeting the most likely sources of contamination.
• If a third sample at the site tests positive after corrective action(s), the facility
will convene a meeting of appropriate personnel to specifically address the
areas and practices.
o Conduct a root cause investigation and put together a corrective action
plan.
o Repeat samples will be included in weekly testing until corrective actions
resolve the problem.

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Appendix III. FDA Investigations Resources

The Food and Drug Administration has several resources posted online that can be helpful to food
processors in understanding what to expect from investigators. The Northwest Food Processors
Association recommends that processors familiarized themselves with these resources.

FDA Investigations Operations Manual

The Investigations Operations Manual (IOM) is the primary policy guide for FDA employees who perform
field investigational activities. The manual is frequently updated, so NWFPA advises processors to check
back on a regular basis for updates. Additions to the manual are highlighted in gray.

http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM291746.pdf

FDA Regulatory Procedures Manual

The Regulatory Procedures Manual (RPM) is a reference manual that provides FDA personnel, such as
inspectors, investigators, and compliance officers, with information on internal procedures to be used in
processing domestic and import regulatory and enforcement matters, such as warning letters and
recalls. This manual is subject to ongoing revisions and additions, so NWFPA advises processors to
review this document periodically for changes effecting their business.

http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074347.
pdf

FDA Compliance Policy Guides

The FDA continually issues compliance policy guides (CPG) which explain the agency’s policy on
regulatory issues related to FDA laws or regulations. They advise the FDA’s field inspection and
compliance staff, as well as the industry, as to the agency’s strategy and policies to be applied when
determining industry compliance. While alternative approaches are often allowed, FDA suggests that
you discuss those approaches with the agency.

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm

FDA Inspection Observations

The FDA makes available on their website data related to inspection and enforcement activity.
Observations are noted on Form 483s during facility inspections and can be found in the Office of
Regulatory Affairs Reading Room, as well as summarized according to the area of regulation.

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORA
ElectronicReadingRoom/default.htm

http://www.fda.gov/ICECI/Inspections/ucm250720.htm

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Citations are compiled into spreadsheets for use by the public and industry allowing them to make
more informed marketplace choices and to encourage compliance.

http://www.fda.gov/ICECI/Inspections/ucm346077.htm

At the end of an inspection, the agency classifies observations made during the inspection as to whether
a condition or practice is violative. If no objectionable conditions or practices are found, an inspection
conclusion of No Action Indicated (NAI) is assigned. If objectionable conditions or practices are found
and they are significant, a conclusion of Official Action Indicated (OAI) is assigned and regulatory action
would be decided. If the District office decides that the significant objectional conditions and practices
don’t warrant regulatory action, a conclusion of Voluntary Action Indicated (VAI) is assigned. FDA
maintains a database of inspection classifications for the public’s benefit on their website.

http://www.fda.gov/ICECI/Inspections/ucm222557.htm

Warning letters issued as a result of OAI inspections are posted and searchable on the agency’s website.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

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